Senior Specialist, External Manufacturing - United States
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Product Quality Manager is responsible for ensuring that all company products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.
- Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture and release of (API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals, medical devices) by means of risk-based quality oversight and on-site supervision, as appropriate.
Primary Activities may include, but are not limited to the following:
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of company and compliance with all governing regulations; review and approve changes to master batch records
- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
- Provide support for audits of EP/ExP by company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
- Oversee repackaging activities in the ExP/EP
- Conduct routine analytical change requests and support process modification change controls
- Stability Program management, including review of stability reports, and Annual Product Review assembly
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements
- Track and monitor operational and quality performance of the external manufacturer/partner
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine
- Support routine process validation; review and approve validation reports/tech transfer
- Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes
- Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.
Education Minimum Requirement:
Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
Required Experience and Skills:
Minimum of five years of experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
Preferred Experience and Skills:
- Strong knowledge of External Manufacturing management, supply chain, and operations
- Lean Six Sigma Product ion Systems training
- Project Management skills
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
- Our company is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Travel: Yes, 25 % of the Time