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EMPLOYMENT OPPORTUNITIES
QUALITY SYSTEMS SPECIALIST I - Boehringer Ingelheim
Type: Full Time
Duration: Permanent
Experience: 3-4 Years
Salary: Commensurate - Commensurate
Location: Bedford, Ohio, USA, 44146.
Boehringer Ingelheim is currently seeking a talented and innovative Quality Systems Specialist to join our team located in Bedford, OH. As a Quality Systems Specialist, you will be responsible for investigating quality issues and reviews the results of manufacturing investigations. Responsible for deviation investigations, out of specification results and atypical results investigations and associated corrective and preventive actions (CAPA). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies? success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and worklife balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Responsibilities:
- Investigates events to gather relevant information necessary to develop investigation. Ensures that reports are aligned with regulatory requirements, site standard procedures and company policies.
- Reviews protocols, analytical results and/or documents associated with investigations. Ensures the compliance with regulations for the quality of the investigations, the identification of the root cause, the identification of the appropriate correctives and preventative actions, and the product impact and disposition.
- Assists with the development of CAPAs and collaborate with stakeholders to ensure that all necessary activities are executed timely and effectively.
- Interface with contract customer representatives to notify of process/product exceptions and determine responsibilities and solutions related to the event.
- Support Domestic and International Regulatory inspections, preparations and corrective actions as needed.
- Representing Quality Assurance at various project and technical meetings, as needed.
- Assist in developing and maintaining various quality systems and programs, as needed.
Qualifications:
- Requires a Bachelor of Science or other related technical discipline
- At least 3 years of experience in a pharmaceutical/ drug (FDA regulated) industry.
- Minimum 1 year experience with 21 CFR 820 Quality System Regulations or ISO standards.
- Minimum 1 year experience in aseptic manufacturing or auditing of aseptic processes.
- Experience in risk management, preferred. Good communication skills, both oral and written
- Intermediate computer literacy with experience working with Microsoft Office, Word, Excel, Power Point. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts preemployment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V.
How to apply: Please copy and paste the following link into your browser address bar:
http://appclix.postmasterlx.com/track.html?pid=ff80808129b8316b0129fa493d6011b3&source=pharmacompliance
Posted 7/26/2010
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ASSOCIATE DIRECTOR, COMPLIANCE - Amylin Pharmaceuticals
Location: San Diego, CA
Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and were always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.
The Associate Director, Compliance position will report to the Chief Compliance Officer and is responsible for the development and implementation of compliance monitoring programs. In addition, this position will lead efforts in the area of healthcare provider cost/expense and other disclosures required under state law.
Responsibilities
- Development and implementation of annual monitoring plans designed to evaluate Amylin adherence to company policies and the adequacy of controls surrounding activities that include interactions with healthcare professionals, customers, or others who may purchase, prescribe or influence the use of Amylin products
- Analyze company risks associated with FDA, OIG and related issues to develop and conduct annual monitoring plans
- Prepare and communicate compliance monitoring results and updates to the Chief Compliance Officer and functions
- Coordinate and conduct monitoring activities, including corrective action plans, with Commercial, Research & Development, Legal and other functional areas
- Assist the Chief Compliance Officer with oversight of corrective action implementation
- Communicate and coordinate with Corporate Internal Audit regarding auditing programs and plans
- Partner with and advise departments to develop and implement comprehensive departmental monitoring processes
- Identify, gather, analyze and verify relevant data through interviews, direct observation and review of electronic and physical information
- Lead efforts to ensure the company meets healthcare provider cost/expense and other disclosure requirements under applicable laws
- Collaborate with compliance team and functions to evaluate and enhance company reporting systems and processes for healthcare provider cost/expense disclosures required by state and future federal law
- Coordinate, collaborate with, advise and direct functions to prepare and file state required disclosure reports covering healthcare provider costs and expenses
- Collaborate with and direct functions to implement any policy or process changes required to meet state law requirements
- Provide advice and guidance to compliance team and functions regarding training covering healthcare provider cost/expense and other disclosure requirements
- Oversee the tracking and reporting of healthcare provider costs/expenses required under state laws
- Identifying, analyzing and verifying relevant financial and other information from financial and other systems
- Providing guidance to employees on compliance and ethics matters
Requirements
- Bachelor's degree required; Compliance and Ethics Professional or other Compliance Certification, and JD is a plus
- 5+ years of industry-related compliance and/or regulatory experience
- CPA or other substantial financial experience preferred
- Understanding of compliance issues facing pharmaceutical/biotech companies
- Demonstrated knowledge and understanding of the required elements of compliance programs
- Experience in drafting and maintaining policies and procedures
- Excellent project management, organizational, communication and presentation skills
- Ability to organize, prioritize and project manage work
- Prepare and work with spreadsheets, dashboards and other documents using computer applications that include Microsoft Word and Excel
- Gather and review data and information from company's financial systems that include Concur and SAP
- Strong detail orientation required
By Challenging Science, Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin's approach and dedication are rooted in the belief that we will be Changing Lives for millions of people. At Amylin, you'll have the chance to truly make a difference in people's lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation and benefits program. Amylin is proud to be an equal opportunity employer.
Visit the link below to apply:
http://careers.amylin.com/jobDetail.asp?id=14025&p=1
AMYLIN
Challenging Science. Changing Lives.
Posted 7/22/2010
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COMPLIANCE SPECIALIST/AUDITOR/SENIOR COMPLIANCE SPECIALIST/AUDITOR - Genentech
For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Now a wholly owned member of the Roche Group, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset.
The following opportunity exists in our South San Francisco, CA, headquarters:
Compliance Specialist/Auditor/Senior Compliance Specialist/Auditor
Responsibilities:
The Healthcare Compliance Office (HCO) Senior Compliance Specialist/Auditor is responsible for conducting complex, investigative, in-depth audits of the Commercial, Development and Medical Affairs organizations pursuant to Genentech's Healthcare Compliance policies, guidelines and Standard Operating Procedures (SOPs) of various groups. This individual designs and effectively executes HCO audits individually or by leading a team comprised of consultants and legal counsel. The position requires some domestic travel for field and vendor interviews. This individual should be committed to fostering a culture of compliance at Genentech by partnering with business owners, HCO counterparts, Legal and Business Practices - and, of course, leading by example.
The candidate will provide oversight and execution of 3-5 audits annually by working independently and with limited supervision, but subject to input and direction by the Associate Director of HCO Auditing & Monitoring.
Requirements:
This position requires a Bachelor's degree; MBA, JD, CPA or other relevant advanced degree is strongly preferred. The applicant must have an in-depth understanding of pharmaceutical or life sciences business and healthcare compliance risk areas. He/she must have at least five years of experience in a healthcare compliance position at a major pharmaceutical or life sciences company or consulting firm, preferably as an auditor, monitor or investigator; or seven years of experience as a finance/general auditor at a major consulting firm or life sciences/pharmaceutical company.
The individual must have demonstrated applied knowledge of laws and regulations related to interactions with Healthcare Professionals, including but not limited to the Anti-Kickback Statutes, Government Fraud & Abuse, Off-Label promotion. He/she must also have the ability to understand, prioritize and communicate healthcare compliance-related risks to sophisticated business personnel; and to apply extensive healthcare compliance and business knowledge to accomplish HCO audit objectives through effective risk mitigation. Strong written and verbal communication skills are required, including the ability to manage conflict and negotiate corrective actions with senior managers. Knowledge of IT, Finance and business systems are also required.
Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. #1000033433. Please use "Web - PCF" when a source is requested. Genentech is an equal opportunity employer.
Posted 6/15/2010
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CORPORATE COUNSEL, GOVERNMENT INVESTIGATIONS - Pfizer, Inc.
Pfizer seeks Corporate Counsel to serve as integral member of litigation team that manages government investigations and related litigation for Pfizer Inc, and all subsidiaries and affiliates in the United States and abroad. Location - New York Headquarters.
Responsibilities include:
- Direct interface with prosecutors and regulators with the U.S. Department of Justice, SEC, HHS Office of the Inspector General, and U.S. Attorney's Offices in Boston, New York, New Jersey, Philadelphia and elsewhere regarding a variety of healthcare law and other types of matters.
- Manage government interactions around U.S. Foreign Corrupt Practices Act (FCPA) with the U.S. DOJ and SEC and foreign prosecutors.
- Work extensively with outside counsel, and maintain responsibility for significant budgets associated with outside law and forensic firms and other third-party providers.
- Collaborate and interact with business clients and other stakeholders at all levels and capacities within the organization (ex. Compliance, HR, Audit, Security, business personnel, etc.).
The candidate must have the following qualifications, skills, and attributes:
- JD degree with a strong academic background;
- Minimum of five years' litigation experience with substantial investigative focus and, ideally, FCPA expertise;
- Ability to work well both independently and as part of a team to resolve complex matters;
- Excellent leadership and collaboration skills;
- Superb oral and written communication, analytical, organizational, and strategic thinking skills;
- Willingness to travel in the U.S. and internationally, as needed; and
- Bicultural experience and languages preferred
Visit the link below to apply:
www.pfizer.com/careers #941145 / Questions: ann.devos@pfizer.com
Posted 6/4/2010
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PFIZER, CONSUMER HEALTHCARE COMPLIANCE LEAD
SR. CORPORATE COUNSEL will serve as Compliance Lead for Pfizer's Consumer Healthcare business which is located in Madison, New Jersey. This position will report to the Compliance Officer for Pfizer's Diversified Businesses and have a close working relationship with the Chief Counsel of the Consumer Healthcare business. The Pfizer Diversified Businesses (PDB) includes Pfizer's Animal Health, Capsugel and Nutritional businesses in addition to Pfizer Consumer Healthcare (PCH).
Responsibilities
- Develop, Implement and oversee PCH's compliance program, including (1) risk identification, assessment and mitigation; (2) development and updating policies and procedures; (3) development of training curriculum and program in key areas; (4) anticipating emerging trends and changes to the political, legal, and regulatory landscape by working with the business; and (5) proactively developing tools to drive compliance within the business.
- Chair PCH's Compliance Committee meetings.
- Partner with other Corporate Compliance Group members on FCPA governance; coordinate and implement FCPA compliance initiatives for PCH.
- Serve as a resource to Corporate Internal Audit and help the business prepare for internal audits.
- Work with the Government Investigations group and the Corporate Compliance Investigations group to manage and understand the docket of compliance investigations and communicate findings to PCH's leadership.
- Work closely with other PDB compliance leads to ensure consistency and leverage best practices.
Qualifications
The candidate must have the following qualifications, skills, and attributes:
- JD degree (or equivalent training and experience that qualifies the candidate to practice law in his/her home jurisdiction) with a strong academic background.
- At least 7 years of progressive professional legal experience ideally involving legal and/or regulatory requirements applicable to marketing and/or promotion of pharmaceutical products and/or consumer products (e.g. privacy, anti-kickback, PhRMA code and consumer industry codes).
- Ability to work well both independently and as part of a team to resolve complex matters;
- Excellent leadership and collaboration skills.
- Excellent writing, oral communication, strong analytical, organizational, and strategic thinking skills.
- Ability to work effectively in a global environment.
- The candidate must be proactive and have initiative.
- Pharmaceutical, consumer or related industry experience strongly preferred.
Visit the link below to apply:
www.pfizer.com/careers # 941244 / Questions: ann.devos@pfizer.com
Posted 6/4/2010
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SENIOR CORPORATE COUNSEL, WORLDWIDE COMPLIANCE PROGRAMS - Pfizer, Inc.
Pfizer seeks Sr. Corporate Counsel to serve as lead compliance counsel supporting legal and global business development teams in connection with mergers and acquisitions and licensing transactions. Position located at NY Headquarters.
Responsibilities include:
- providing compliance counsel for, and conducting due diligence on, product acquisitions, licenses, joint ventures, and research collaborations as well as product divestitures and corporate acquisitions; and,
- drafting reports and memorandum to Sr. Management on the results of due diligence findings.
Qualifications include:
- Minimum of 7 years of significant Compliance experience, including a strong background and knowledge of the Foreign Corrupt Practices Act and US healthcare and regulatory laws.
- Applicant will ideally have significant experience handling joint ventures, licensing, product acquisitions and divestitures and M&A transactions.
- International experience and knowledge of other languages are a strong plus.
- Top tier law firm experience preferred. Must have excellent written and oral communication skills, and strong analytical capabilities.
- Must have the ability to take a leadership role in managing and coordinating the compliance aspects of complex business transactions.
- J.D. or equivalent from an accredited law school and must be a member of the Bar in good standing.
- Domestic and International travel may be required.
Visit this link to apply: www.pfizer.com/careers #940821
Questions: ann.devos@pfizer.com
Posted 5/19/2010
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