The 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.
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 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 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
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 some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
Solves range of straight forward problems
Receives moderate level of guidance and direction
Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed
Explains information and persuades others in straightforward situations
Accountable for technical contribution to project team or sub-team; may manage/lead a small project team
Ability to work across boundaries; developing interpersonal, relationship building and leadership skills
Communicates easily in English both verbally and in writing
Knowledge of External Manufacturing management, supply chain, and operations
Lean Six Sigma Systems training an advantage
Fluent in English language (reading, writing and speaking)
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at email@example.com
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OFCCP EEO Supplement
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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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Merck & Co., Inc.