Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Responsible for the management, oversight, and communication on all matters related to the Quality Assurance and cGMP status of products governed by Alliance relationships – including manufacture, testing, packaging, storage, and distribution of sterile/non-sterile pharmaceutical products, Active Pharmaceutical Ingredient (API) intermediates, API, biologics, drug delivery devices and consumer care products – under the direction and/or on behalf of the Director of External Quality Assurance. These activities include involvement in most aspects of Supply Chain operations and Quality systems oversight related to ensuring the quality of products produced from Alliance partnerships; and requires a high degree of independence and proficiency with the following ‘soft skills’ – negotiation, influencing, building trust and driving continuous improvement.
Responsible for the integration and oversight of our Company internal Quality functions with the partners, establishing and maintaining a highly collaborative and functional relationship with external partners, generation and maintenance of Quality agreements, as well as overseeing release of manufactured products (in support of Supply In/Out relationships). Ensures the quality performance of external Alliance partners through direct oversight, support and technical advice, counselling to senior leadership of the external partner and providing on-site supervision as appropriate. The successful candidate will also exercise a leadership role in monitoring and maintaining both our Company and the alliance partner’s compliance with cGMP regulations, all applicable regulatory requirements, company policies and contractual obligations.
- Possesses a combination of analytical/scientific and leadership skills to effectively manage and control all activities necessary to support a total Quality Systems program governing Alliance relationships. In addition, may serve as the functional area SME for internal QMS design and deployment; specifically as it relates to capturing elements of Alliance Management.
- Reports to the Director of External Quality Assurance. Receives guidance on policy issues as well as general and specific direction with regards to operations from the Director but functions independently. Keeps the Director informed on the status of operations and problems.
- Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
- Assures the development and maintenance of a Quality Agreement with the Alliance partner. Acts as a Quality expert on our Company’s behalf regarding contract negotiations and potential new business deals and may provide input into the development of contractual agreements.
- Coordinates the Quality Assurance of the supply chain and product release responsibilities for the Alliance relationship. Sets up and maintains suitable formal communication programs and forums to track and monitor operational and quality performance. Supports escalation of any issues and suitable resolution.
- Serves as the External Site Quality Lead for the Alliance partner and central point of contact (i.e. liaison) for all communications between the partner and internal company personnel.
- Closely collaborates with appropriate business and/or operations areas to achieve Manufacturing Division and our Company objectives.
- Executes a program of Quality oversight for the Alliance relationship based on the contractual and Quality Agreement obligations, product type, capabilities and quality performance of the partner.
- Maintenance and oversight of ongoing supplier performance management, including but not limited to: regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews (APRs).
- Reviews all audit outcomes pertaining to the External/Alliance partner and ensures appropriate and timely corrective actions are identified and implemented (as needed).
- Where required, oversees the release of 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 our Company and in compliance with all governing regulations.
- In collaboration with other internal company departments Chemistry, Manufacturing and Control/Global Technology Operation (CMC/GTO), ensures change control is suitably managed and communicated.
- Ensures suitable coordination of Quality complaints, deviation investigations (including Fact Findings and any product recalls) involving the Alliance partner.
- Provides support and develops presentations for Quality Council (QC) meetings (as needed). In addition, may serve as the QC Coordinator for the platform; providing oversight for presentation content and issuance of meeting minutes.
- In situations where direct reports are involved; responsible for the supervision of personnel that provide quality oversight of contract manufacturing organizations contracted for the manufacture of API intermediates, API, sterile and non-sterile pharmaceuticals, packaging, drug delivery systems and consumer care products for our Company.
This position can be based at any of our company’s US locations.
Education Minimum Requirements
- At least a bachelor’s degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, Science, Engineering, or related areas of study.
Required Experience and Skills
- At least 7 years of relevant work experience in the pharmaceutical, biotech, or related industry
- Expansive knowledge in product Quality Assurance and Quality Control competencies
- Solid and demonstrated interpersonal, communication, negotiation, and persuasion abilities
- Conversant with all domestic and foreign regulations governing pharmaceutical operations
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.
Who we are …
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.
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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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