External Quality Assurance - Senior Product Quality Manager H/F (BB-4DA6D)
Found in: Neuvoo UK
The Senior Product Quality Manager is responsible for ensuring that all 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 External Party manufacture and release of (API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals) by means of risk-based quality oversight and on-site supervision, as appropriate.
PQM will support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of markets, historical performance (production and compliance), new product or market launches, historical relationship between with the partner, manufacturing process complexity.
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 and compliance with all governing regulations; review and approve changes to master batch records
• Manage routine and complex 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 External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented
• Oversee repackaging activities in the External Party
• Conduct routine and solves complex 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 and work with supplier to develop CAPA plans
• 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
• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
• Previous 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
• Solves complex problems; takes a new perspective using existing solutions
• Works independently, receives minimal guidance
• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME
• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others
• Explains difficult issues and works to build alignment around a complex situation
• Accountable for a medium sized project with minimal resource requirements, risk and/or complexity
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
• Communicates easily in English both verbally and in writing
• Strong knowledge of External Manufacturing management, supply chain, and operations
• Lean Six Sigma Systems training an advantage
Travel: • Ability to travel up to 10% of the time
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Current Employees apply
Current Contingent Workers apply
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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