Associate Director, Quality Assurance

Job Description

Our Research and Development division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world.

Our Research Quality (RQ) encompasses several functional quality groups who focus on technology and systems, suppliers, and internal processes. The functions perform both proactive quality oversight activities and auditing and provide support to strategic initiatives across our Research and Development division. The Good Laboratory Practice (GLP) team provides independent quality oversight assuring that the company’s non -clinical studies and internal clinical analyses are conducted in compliance with regulatory expectations.

Essential functions include but are not limited to in partnership with GLP QA Functional and Operation Leads, support the implementation and management of the QA strategy. Independently facilitates specific tasks in compliance with appropriate government regulations (e.g., FDA GLPs, OECD guidelines), guidance documents, Company policies, and departmental Standard Operating Procedures (SOPs). This position is responsible for the execution and closure of the assigned global GLP QA audit activities ensuring that the current regulations, policies, and procedures are adhered to at all our company's sites (domestic and international) and at contract facilities worldwide. Assignments are of increased complexity and solves complex problems. Will function as a team or project lead as required promoting open discussion of issues.

Primary Responsibilities:

• Facilitates communication and alignment with key stakeholders upstream and downstream.
• Conducts wide range of GLP, regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits in accordance with QA risk-based processes. regulations/guidelines, as well as our Company policies, procedures, and industry standards.
• Serves as a Lead Liaison for all QA activities supporting regulated activities within our Company sites (domestic and international) and contract facilities worldwide.
• Provides expert level knowledge of assigned major project/program areas as related to quality assurance issues and strategies. Responsible for the daily activities for assigned projects/programs, including prioritizing, planning, scheduling, monitoring, and communicating issues to appropriate personnel.
• Independently functions as a lead auditor to ensure compliance to regulations, international guidelines, our Research & Development Division policies, and departmental SOPs in accordance with QA SOPs. Provide regulatory perspective or quality advice and guidance to the stakeholder areas and within QA.
• Works independently by seeking guidance only in the most complex situations. Makes decisions guided by policies in non-standard situations which impacts the achievement of client, customer, operational, project or service objectives. Manages own work to meet competing priorities and deadlines (stakeholder and GLP QA). Documents and and/or tracks audits and inspections as required. Assures timely resolution of findings and reports all findings to appropriate personnel and management.
• Maintain expert-level knowledge of all applicable regulations and guidelines worldwide, as applicable to stakeholders, and ensure the current regulations, policies and procedures are adhered to. Reviews and interprets, using own discretion, regulatory citations and other pertinent information and distributes to appropriate personnel. Acts as a resource for colleagues across areas. Explains difficult concepts and influences others to adopt a different point of view, when appropriate
• Develops, coordinates and/or conducts education and training on compliance requirements for our Research & Development Division or other stakeholder personnel when needed. Provides training and mentorship to less experienced QA staff. Provides project specific feedback as appropriate. Leads and or participates on, department committees supporting internal functions and/or evaluating business processes for improvement opportunities.
• Manage large or multiple projects with moderate resource requirements, risk and/or complexity as directed by management. Solves/leads others to solve complex problems; takes a broad perspective to identify innovative solutions.
• Leads appropriate and timely escalation of quality issues, including issues of significant deviation with projects, to the Functional Lead and GLPQA Head. Participates in the assessment of potential root cause and Corrective Actions Preventive Actions (CAPAs) associated with Significant Quality Issues, as needed.
• Key point person during inspection management and provides independent support as appropriate.
• Represents GLP QA and or QA on interdivisional and cross-functional teams, as needed.

Education:

• Minimum Required: Bachelor's Degree in appropriate Science, IT or Engineering discipline.

Required:

• Minimum 8 years of audit experience in the regulated pharmaceutical, biopharma/biologics or related industry.
• Extensive knowledge of FDA and OECD GLP regulations
• Experience leading audits.
• Strong leadership skills and the ability to lead cross-functional teams.
• Experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators.
• Excellent attention to detail.
• Proficient with digital tools and computer applications; competency in Microsoft PowerPoint, Excel, and Word.
• Excellent verbal and written communication and presentation skills.
• Ability to independently prioritize and manage multiple projects and tasks simultaneously, ensuring timely delivery and meeting business objectives.

Preferred:

• Experience with computer system applications (e.g., Pristima, electronic laboratory notebooks, Veeva, Laboratory Information Management Systems (LIMS), Empower).
• Experience leading and/or supporting US and EU health authority inspections.
• Superior collaboration and teamwork skills.

# eligibleforERP

Required Skills:

Audit Management, Collaborative Leadership, Project Leadership, Quality Assurance Systems, Quality Oversight, 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.

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

08/27/2026

*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.