Associate Director, External Quality
Job Description
Join our External Manufacturing Quality leadership team and help ensure the quality, compliance, and performance of our global Animal Health external manufacturing network. As Associate Director, Global Quality External Manufacturing (Animal Health), you will lead external quality oversight across third-party partners in North America, Mexico, and Canada, while managing a remote quality team responsible for batch review, product release, and local quality operations. You will act as the primary Quality liaison between external partners and internal teams, helping ensure all products are manufactured, packaged, tested, and distributed in compliance with company standards and global cGMP/regulatory requirements.
Key Responsibilities
Lead external quality management and oversight of third-party manufacturing partners and CMOs Serve as the Quality point of contact for external partners and internal stakeholders Lead external manufacturing Quality team in Mexico and Canada specifically for review, packaging and release for all local and imported products. Ensure partner compliance with GMP requirements, Quality Agreements, and commercial commitments Oversee batch review, product release, change control, validation, audits, and remediation activities Support quality system improvement, risk management, and continuous improvement initiatives Manage team performance, budget, and headcount planning Partner cross-functionally to support operational excellence, compliance, and supply continuity Education Requirements Bachelor’s degree in Veterinary Science, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or related field Required Experience and Skills 10+ years of experience in a pharmaceutical company and/or External Manufacturing Organization 2+ years of direct people leadership experience -Proven remote management, team leadership, and performance accountability skills Strong background in Quality Systems, QA/QC, global GMP, and regulatory requirements Demonstrated experience in external quality management and third-party oversight Strong problem-solving, risk management, communication, negotiation, and influencing abilities Required Skills: cGMP Compliance, External Manufacturing, Leadership, Manufacturing Quality Management, People Management, Pharmaceutical Manufacturing, Quality Compliance, Quality Operations, Quality Systems Compliance Preferred Skills: Quality Leadership, Quality Management Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance 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. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Job Posting End Date: 05/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Apply To This Job