QA Associate Director

Job Description

An amazing opportunity has arisen for an Associate Director Supplier Quality Assurance (SQA) in our company. This position will be responsible for ensuring the integrity and safety of our products through strategic oversight of global API suppliers.

What you will do:

Bring energy knowledge innovation and leadership to carry out the following:

• Serve as the primary Quality liaison for strategic API suppliers ensuring compliance with GMP company standards global regulations Annex 1 where applicable and the company Quality Manual.
• Maintain and negotiate Quality Agreements; assess supplier capability using risk-based tools; plan and lead audits; and drive effective CAPA with verification of effectiveness.
• Strengthen supplier Quality Management Systems by overseeing change control deviations CAPA OOS/OOT document control training internal audits and management review.
• Lead investigations into deviations OOS/OOT microbiological excursions stability issues and complaints; ensure robust root-cause analysis remediation and required regulatory reporting.
• Provide oversight for technology transfers and process validation; drive inspection readiness; represent the company during regulatory interactions and inspections.
• Monitor supplier performance collaborate with cross-functional partners escalate critical risks and coach internal and supplier teams in a global matrixed environment.

What skills you will need:

In order to excel in this role you will more than likely have:

• Bachelors degree in Chemistry Pharmacy Biology Microbiology Chemical Engineering or a related scientific/engineering field.
• 8 years of experience in GMP-regulated environments (API and/or drug product) with responsibility in Quality Assurance/Quality Control and manufacturing or technical operations.
• Strong working knowledge of EU FDA and relevant global regulations with familiarity in ICH guidelines and Annex 1 where applicable.
• Hands-on experience with QMS elements including change control deviations CAPA OOS/OOT investigations document control training internal audits and management review.
• Ability to lead root-cause analysis and remediation for deviations OOS/OOT microbiological excursions stability issues and complaints.
• Fluent in English with the ability to communicate clearly in a global virtual environment; additional language skills are an advantage.
• Strong interpersonal negotiation and influencing skills with the ability to work effectively across cultures and in matrixed organizations.
• Experience supporting technology transfers process validation regulatory inspections and inspection readiness is preferred.
• Willing and able to travel approximately 25% domestically and internationally.

Why Join Us

For over 130 years we have pioneered groundbreaking science. Today we are driven by continuous innovation to develop breakthrough medicines vaccines and technology. Rooted in direct experience on the farm and in the clinic we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals helping them manage their vital responsibility with confidence. Because when it comes to animal health no one sees it like we do.

So if you are ready to help shape the future of quality and make a meaningful impact please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway 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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