New · posted Nov 5
Merck · Pharmaceuticals
Live Virus Vaccine Quality Operations Lead
- West Point, PA
- On-site
- Full-time
- Director
The role
Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director within Quality is responsible for providing Quality direction and oversight to one of our sites in the quality systems, such as Training, Documentation (including Standard Operating Procedures and Master Batch Records), Annual Product Review, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with Regulatory requirements.
The individual is an Advocate and Leader for the development, execution and deployment of the site and our priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for Quality oversight of vaccine formulation and filling operations as well as the associated Quality Systems. The qualified candidate ensures compliance to Divisional, Company, and Site standards and procedures. The incumbent manages a team of Quality Specialists, responsible for elevating our compliance posture. This role partners with the Operations and Technical Operations Leaders to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements.
The qualified candidate must demonstrate strong analytical and scientific acumen to assist with troubleshooting of processes and systems. Excellent leadership capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required. The incumbent will actively participate in external regulatory inspections.
Primary activities include but are not limited to
1.) Directly leads activities in the execution of quality system functions relating to GMP compliance; additionally, champions multi-department teams regarding various compliance initiatives and assessments.
2.) Coordinates and directs a team of multi-disciplined professionals in areas of process and systems as they relate to support and enhancements of the quality system(s)
3.) Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Responsible for hiring and ensuring personnel are trained and performing per expectations.
4.) Manage and coach the Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities.
5.) Ensure that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
6.) Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums as well as strategic initiatives.
7.) Acquire and maintain technical process knowledge relevant to operations and testing. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations.
8.) Proactively partner to identify and implement continuous improvement actions to solve problems and implementation corrective and preventative including but not limited to reducing deviations, reducing lead-time, improving safety and eliminate waste, while maintaining compliance.
9.) Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents.
OR
- Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
What you need
Minimum Education Requirements and Experience
- Bachelor's Degree in Science, Engineering, or another technical field with eight (8) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
Required Experience and Skills
- Minimum two (2) concurrent years’ experience managing direct reports.
- Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
Required Skills
Achieving Objectives, Achieving Objectives, Adaptability, Aseptic Handling, CAPA Management, cGMP Regulations, Compliance Analysis, Compliance Risk Management, Continuous Improvement Techniques, Corrective Action Management, Critical Thinking, Deviation Management, GMP Compliance, Government Regulation, Leadership, Master Batch Records, People Leadership, People Management, Production Management, Quality Assurance Systems, Quality Control Management, Quality Control Systems, Quality Management Systems (QMS), Quality Manuals, Quality Risk Management {+ 8 more}
Travel Requirements
No Travel Required
Preferred Experience and Skillsnice to have
- Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need. Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and compliance risk.
- Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm.
- Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
- Demonstrated experience of interacting with site, divisional or regulatory audits
- Demonstrated ability to create an engaged workforce using Inclusion as the How
- Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion. MPS experience - LSS Green Belt certification or equivalent experience.
- Demonstrated success with Talent Management including leading and mentoring
- Proven ability to manage multiple projects simultaneously.
- Applies knowledge of internal/external business challenges to improve products, processes, or services.
- Solves complex problems; takes a new perspective using existing solutions.
- Works independently, receives minimal guidance.
- Demonstrated self-starter with capability to develop innovative solutions to challenges.
- Aseptic/sterile processing experience
- Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing
Pay and benefits
$129,000 – $203,000 a year
Employer providedAdditional 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
Medical, dental and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
West Point, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in West Point, PAWorking conditions
1st - Day
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/12/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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:
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 - Pennsylvania - West Point
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 https://jobs.merck.com/us/en/compensation-and-benefits.
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.
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Director roles in the US17 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $129,000 | — | $203,000 |
| All US (middle half) | $188,000 | $200,000 | $231,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 87 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- GMP and compliance11
- Documentation and SOPs10
- Quality systems and risk8
- Lab testing and methods4
- Investigations and CAPA3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 40
- Open roles
- 40
- Distinct roles
- 7
- Locations
By discipline
- Clinical29 73%
- Quality6 15%
- Regulatory5 13%
By level
- Director29 73%
- Associate & Specialist5 13%
- Senior & Principal4 10%
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Live Virus Vaccine Quality Operations Lead at Merck
Applications close November 12. $129K–$203K a year, employer provided.