Allergan Manager, Contract Mfg Quality in Parsippany, New Jersey
Manager, Contract Mfg Quality
Parsippany, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/794/other-jobs-matching/location-only
Oct 06, 2016Post 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 pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.
Our success ispowered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Be part of the dynamic Third Party & Commercial Quality (TPCQ) team responsible for innovative branded pharmaceuticals, over-the-counter medicines and combo products.
Under general direction, manages the evaluation of products supplied to the Company by third parties. Responsible as Third Party Quality Site Owner for products supplied to the Company by third parties. As site owner, assure that the product is manufactured andcontrolledin accordance with Company standards, registrations and regulations both domestically and internationally.
Essential Job Functions:
This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
Review of batch records, testing, stability, annual product reviews, validations, change controls and master documentation.
Support and provide quality inputfor product and/or analyticalmethod transfers as well as activities affecting validation and qualification strategies such as product and/or process improvement initiatives.
Negotiate and establish quality agreements and provide quality input for other business agreements for third party manufacturers, suppliers and partners.
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.
Monitor quality metrics/ key performance indicators for contract sites and contribute to Business Review and Quality Management Review meetings.
Work with various internal departments as part of supplier selection, development and launch projects and other initiatives at third parties.
Assist in a variety of regulatory related support activities such as field alerts and recall execution support, as required.
As a member of the TPCQ Americas team, develop and implement StandardOperating Procedures (SOP's) to assurecompliance with regulations, Allergan corporate standardsand contractual agreements.
Knowledge and skills:
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.
English usage, spelling, grammar and punctuation
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.
Role requires some travel (approximately 10%)
Bachelor's Degree in Chemistry, Pharmacy or related field from an accredited college or university, and five (5) – seven (7) years pharmaceutical manufacturing experience, three (3) of which must be in a quality capacity or an equivalent combination of education and experience.