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.
Establish and reinforce master data management and 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
**Required Skills: **
Audit Management, Compliance Investigations, Data Governance, Data Integrity, Deviation Management, Global Program Development, Good Manufacturing Practices (GMP), In Process Quality Control, Master Data Management (MDM), Pharmaceutical Quality Assurance, Pharmaceutical Quality Control (QC), Quality Assurance Systems, Quality Operations, Quality Oversight, Quality Risk Assessment, Quality Risk Management, Quality Systems Compliance, Quality Systems Documentation, Regulatory Compliance
**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.
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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:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/26/2026
***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. **