Job Description
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented.
Primary Activities
- Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing
- Partner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings
- Gather regulatory intelligence and partner with our Company and CMO management to prepare sites for audits and inspections. Assists sites during audits and inspections to ensure successful outcomes
- Monitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality/Management councils
- Provide guidance and consultation services for regulatory reporting (e.g., BPDR, DPR)
- Author and/or review global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirements
- Actively participate in industry organizations such as PDA, PQRI, PhRMA, ISPE, etc.
Education And Required Experience:
- Bachelors degree in Life Sciences, Chemistry, Engineering or related relevant discipline and 10+ years of demonstrated experience within Quality compliance within large molecule manufacturing industry
- Expert knowledge of GMP requirements for multiple regulatory agencies
- Expert knowledge of large molecule manufacturing processes (for biologics and/or vaccines) and sterility assurance requirements
- Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS
- Experience in health authority inspections
Required Skills:
- Drive Results – set clear performance standards, overcome obstacles; accountable for actions and achieve results
- Make Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
- Act with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate
- Foster Collaboration – ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment
- Make Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
- Act with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate
Preferred Skills/Experience:
- Experience working for a health authority as an inspector, investigator, compliance officer, reviewer, or assessor
- Experience creating or assessing remediation plans
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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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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$169,700.00 - $267,200.00
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:
50%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
N/A
Required Skills:
Biological Sciences, Biologics, Biopharmaceutics, Corrective and Preventive Action (CAPA), Detail-Oriented, Driving Continuous Improvement, GMP Compliance, Manufacturing, Pharmaceutical Quality Control (QC), Preventive Action, Quality Assurance (QA), Quality Assurance Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance, Regulatory Inspections, Vaccine Manufacturing
Preferred Skills:
Quality Control Reviews, Remediation Plans
Job Posting End Date:
09/15/2025
- 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.
Requisition ID:R355668
