Job Description

We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal and external contract manufacturing organizations (CMOs). This critical leadership role will collaborate with a network of professionals responsible for the manufacturing of active pharmaceutical ingredients (APIs) and finished products, including biologics and vaccines.

As a trusted GMP compliance expert, you will drive regulatory excellence, support health authority inspections, and ensure robust corrective and preventative actions (CAPA) are effectively implemented to maintain the highest quality standards

Key Responsibilities:

• GMP Compliance Leadership: Serve as the subject matter expert (SME) on current good manufacturing practices (CGMP) for pharmaceutical manufacturing, including large molecule manufacturing, guiding compliance for internal and external teams worldwide.

• Inspection Readiness & Support: Supports preparation efforts for regulatory audits and inspections, including a holistic lifecycle support for pre-approval inspection (PAI) for the company's growing pipeline of products and launches.

• CAPA Management: Collaborate with company and CMO teams to develop, monitor, and verify CAPA plans addressing global audit and inspection findings, ensuring timely and effective resolution.

• Regulatory Intelligence & Trend Analysis: Gather and analyze regulatory updates and inspection outcomes to identify trends, drive improvements, and report findings to senior quality and management councils.

• Regulatory Consultation:  Offers proactive interpretation and consultation to project teams and sites on global pharmaceutical regulations, guidelines, compliance hot topics, policies, and procedures.

• Industry Engagement: Represent the company in key industry organizations such as PDA, PQRI, PhRMA, and ISPE to stay at the forefront of regulatory and quality best practices.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.

• 10+ years of progressive experience in Quality Compliance, preferably within large molecule manufacturing (biologics and/or vaccines).

• Deep expertise in GMP requirements across multiple regulatory agencies (FDA, EU, ROW)

• Strong understanding of different pharmaceutical manufacturing processes, including Low Bioburden and sterile operations.

• Proven track record supporting health authority inspections and implementing effective CAPA.

• Ability to interpret and apply regulatory expectations to maintain a robust Quality Management System (QMS).

Core Competencies:

• Drive Results: Set clear goals, overcome challenges, and deliver measurable outcomes.

• Decisive Judgment: Make timely, data-driven decisions with confidence and discipline; demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions

• Courage & Integrity: Advocate for compliance with transparency and escalate issues appropriately.

• Collaborative Leadership: Influence and align diverse teams to achieve consensus and shared objectives.

Preferred Experience:

• Prior experience working within a health authority as an inspector, investigator, compliance officer, or assessor.

• Expertise in developing or evaluating remediation plans following regulatory inspections.

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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Required Skills:

Audit Management, cGMP Regulations, Change Management, Collaborative Leadership, Communication, Corrective and Preventive Action (CAPA), Decision Making, Detail-Oriented, Driving Continuous Improvement, Global Team Collaboration, GMP Compliance, Good Manufacturing Practices (GMP), Inspection Readiness, IS Audit, Management Process, Manufacturing Processes, Pharmaceutical Manufacturing, Quality Improvement Programs, Quality Management, Quality Management Systems (QMS), Quality Operations, Regulatory Compliance, Regulatory Inspections

 Preferred Skills:

Job Posting End Date:

09/7/2025

*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.