Associate Director, Quality Assurance

Job Description

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our Company's Research Laboratory Quality Assurance and is responsible for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence and the Quality Management System (QMS).

The Associate Director, Quality Systems is responsible for execution, oversight, and continuous improvement of globally governed quality system processes in support of the clinical supply chain for investigational medicinal product within our company's Global network. The position strengthens the effectiveness, consistency, and sustainability of deviation management, CAPA, change control, quality risk management, and data governance during a period of heightened regulatory focus and organizational transformation.

The responsibilities of this role included, but are not limited to:

• Drive Quality Systems Transformation initiatives focused on deviation management, CAPA effectiveness, change management, quality risk management, and data governance.
• Strengthen standardization and continuous improvement of global quality system processes to ensure consistent application, transparency, and inspection readiness.
• Reinforce data governance/ data integrity controls that underpin right-first-time execution and regulatory confidence.
• Provide quality system expertise to ensure processes remain in a state of control, compliant with global regulatory requirements and internal standards.
• Act as a change agent to enable durable quality system and quality culture improvements through system-level rigor, governance, and traceability.
• Partner cross-functionally with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
• Support management oversight activities by developing and monitoring quality system metrics and key performance indicators.
• Author, review, and approve quality system documentation and governance materials in accordance with established procedures.
• Maintain expert-level knowledge of GxP requirements, regulatory expectations, and industry trends, providing interpretation and guidance to stakeholders.

Education Minimum Requirement:

• B.S., M.S., or Ph.D. in a science or engineering discipline.

Required Experience and Skills:

• Minimum 8 years (B.S./M.S.) or 5 years (Ph.D.) in the pharmaceutical or biotechnology industry.
• Demonstrated experience in Quality Systems, Quality Assurance, Compliance, or related GxP-regulated roles.
• Extensive working knowledge of global GxP requirements and Pharmaceutical Quality System principles.

Preferred Experience and Skills:

• Proven ability to drive continuous improvement and standardization across complex quality systems.
• Strong analytical, problem-solving, and decision-making skills.
• Effective oral and written communication, with the ability to influence across organizational boundaries.
• Experience working within globally governed models and partnering with site and functional stakeholders.
• Ability to manage ambiguity while maintaining rigor, consistency, and control.
• Effective negotiation skills and project management abilities

#eligibleforERP

Required Skills:

Compliance Investigations, Data Integrity, Deviation Management, Good Manufacturing Practices (GMP), Managing Ambiguity, Process Standardization, Project Leadership, Quality Assurance Systems, Quality Compliance, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Training and Development

Preferred Skills:

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:

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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 primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$129,000.00 - $203,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

10/19/2026

*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.