Allergan Senior Manager, Third Party Quality in Madison, New Jersey
Senior Manager, Third Party Quality
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/6204/other-jobs-matching/location-only
Aug 03, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Be part of the dynamic Third Party & Commercial Quality (TPCQ) team responsible for a portfolio
of products that include Natural Health Products, Cosmetics, OTCs and Drugs.
Under general direction, manages the evaluation of products supplied to the Company from the Third Parties and assures that the product is manufactured and controlled in accordance with Company standards, registrations and regulations, both domestically and internationally.
Main Areas of Responsibilities
Oversight and approval of the activities at the Third Parties for all aspects, including but not limited, to the Quality Management System, product disposition and market release, deviations, CAPAs, stability, annual product review, complaints, vendor approval, validation protocols, method transfers, quality agreements and oversight of outsourced Lead investigations into product non-conformances and deficiencies.
Assure that all investigations are properly documented, and that corrective actions for prevention of reoccurrence are completed in a timely manner.
Apply risk management principles in data analysis, decision-making and reporting processes within the areas of responsibility.
Assure responsible Third Parties are compliant with cGMPs, regulatory and corporate compliance requirements and contractual agreements.
Support or manage, as appropriate, communications with Regulatory Authorities including both written and verbal, such as for Field Alerts.
Responsible for ensuring all third party related Agency communication and/or notification activities are consistent with regulatory and company requirements.
Support, if needed, the Third Party during any regulatory agency inspections for Company’s products.
Negotiate and establish quality agreements and provide quality input for other business agreements for third party manufacturers, suppliers and partners.
Monitor quality metrics/ key performance indicators for contract sites and contribute to Business Review and Quality Management Review meetings.
As a member of the TPCQ team, develop and implement Standard Operating Procedures (SOP's) to assure compliance with regulations, Allergan corporate standards and contractual agreements, as necessary.
Strong knowledge of drug regulations and guidelines. Knowledge in Canadian, European and other global regulations also an asset.
Pharmaceutical processes, principles, practices and their application.
Responding to inquiries from management, employees and regulatory agencies.
Researching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data.
Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures or techniques for resolution
Administering, and interpreting contractual agreements.
Excellent interpersonal, oral and written communication skills.
Demonstrated leadership in managing projects and/or product launches and ability to work independently.
Excellent negotiation, problem solving and prioritization skills. Strong time management skills, able to manage multiple projects, duties and assignments.
Ability to work in a team, both in person and remotely and across various departments.
Minimum of seven (7) - ten (10) years of progressive management experience; preferably in the pharmaceutical industry and including engagement of outsourced service providers such as manufacturers and packagers.
Extensive knowledge of the Regulations/GMP’s and experience with regulatory authorities including at a minimum the FDA. Knowledge of other global regulatory authorities is an asset.
The ability to influence vertically and horizontally across the organization is essential.
Must be able to travel, including outside of USA. Travel is estimated to be 20%-25%.
Bachelor’s Degree required, procurement related degree preferred.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.