Our Quality Assurance group ensures all materials in our products are manufactured, processed, tested, packaged, stored, and distributed as aligned with our incredibly high standards of quality and meeting all regulatory requirements.
Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Position of the External Site Quality Lead should possess a unique combination of analytical and scientific skills in order to effectively manage and control all activities necessary for support of a Quality Operations program governing manufacture, testing, packaging, storage, and distribution of API intermediates.
The role receives guidance on policy issues and direction with regard to operations, but functions independently.
Core elements enabling success in the role include :
Assure that the Quality Operations department of the External Partner (EP) operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations, i.
e. Good Manufacturing Practice (GMP), etc.
Through proactive input, ensure the development and maintenance of Quality Agreements with EPs
Execute a program of calibrated quality oversight based on product type, capabilities, and quality and compliance performance of the EP
Primary accountability in oversight of an EP may involve releasing API intermediates, API to other sites and / or to the market with the assurance that the goods were produced in conformance to all applicable policies and procedures of our company and compliance with all governing regulations
Before shipment, ensure that products manufactured by the plant have the correct quality and identity, meet all pertinent specifications and special needs, and have been produced by approved processes and under proper conditions
Be accountable for Quality assurance and control functions to include direct guidance to EPs, coordination and oversight for product testing, as well as other relevant components as established by applied calibrated quality oversight.
These components may include review of batch documentation and deviation investigations
Be accountable for maintenance and oversight of ongoing supplier performance management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews
Review all audit outcomes pertaining to the EPs and ensure appropriate and timely corrective actions are identified and implemented
Monitor efforts to improve EPs quality and reliability through ongoing oversight and formal communication programs and forums
Provide guidance to EPs to facilitate and validate new product introductions
Provide compliance input and guidance, as appropriate, for implementation of systematic methodology and process development initiatives.
In conjunction with other internal departments, ensure that EPs are inspection ready for all new product introductions or transfers
Provide support and develop presentations for Quality Council meetings
Provide oversight for presentation content and support issuance of minutes
Assist in the coordination of significant investigations including Fact Findings and product recalls as needed
Operate in a safe and efficient manner and in compliance with our Manufacturing Division Q.O. Safety and Health Policy
Conduct quality due diligence assessments for pre-approval considerations of new EPs
Partner with the EP in remediation of due diligence and pre-contract audit gaps
Act as the Quality expert on the company’s behalf regarding contractual negotiations and provide input into the development of commercial contractual arrangements with the EP on quality related terms
Partner with the regulatory compliance liaison on the company’s behalf to interface with regulatory agencies
Closely partner with appropriate business and operations areas to achieve manufacturing division objectives
Qualifications and Skills
BA / BS Degree in Science, Engineering, or other relevant technical discipline, i.e. MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent
Demonstrated success in the Pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control, including solid knowledge of global GMP Quality Systems and regulatory requirements
In-depth expertise in API manufacturing with a solid overview of external manufacturing preferred
Strength of scientific skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external parties / partners that manufacture, package, analyze, release, store and / or distribute product
Broad knowledge of manufacturing operations, External Supplier management, supply chain, QA / QC, including engineering, materials, R&D, production, etc.
Be absolutely fluent with all domestic and foreign regulations and compendia governing plant operations with some level of contractual and financial awareness needed
Be proficient in analyzing complex product, production, and testing issues, and have demonstrated scientific problem-solving capabilities
Possess strong communication, networking, and relationship building skills
Work independently, with guidance in only the most complex situations
Act as a resource for colleagues across multiple areas
Ability to manage large or multiple small projects with moderate resource requirements, risk and / or complexity
Anticipate internal / external business and regulatory / compliance issues; recommend product, process or service improvements
Fluency in English both verbally and in writing
Ability to make decisions in an ambiguous environment
Lean Six Sigma expertise
Ability to travel 25% of the time on short notice
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.
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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.
Employee Status : Regular
Relocation : No relocation
VISA Sponsorship :
Travel Requirements :
Flexible Work Arrangements :
Shift : 1st - Day
1st - Day
Valid Driving License :