

New · posted Nov 5
Merck · Pharmaceuticals
Manager, Quality Assurance Second Shift
- Durham, NC
- On-site
- Full-time
- Manager
The role
Our Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.
The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product. The focus for the position includes all aspects of Shop Floor QA oversight supporting Second Shift (Evening Shift).
OR
- Master’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with three (3) years in the pharmaceutical industry or highly regulated industry
What you need
Minimum Required Education and Experience
- Bachelor’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry.
Required Experience and Skills
- Minimum two years in aseptic manufacturing or other clean room environment
- Minimum one year in people management or equivalent direct leadership experience.
- Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
- Effective decision making, problem solving and communication. Ability to manage multiple priorities.
- Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
Required Skills
Analytical Problem Solving, Analytical Thinking, cGMP Compliance, Decision Making, Detail-Oriented, Driving Continuous Improvement, Key Performance Indicators (KPI), People Leadership, Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management Standards, Quality Management Systems (QMS), Root Cause Analysis (RCA), Supplier Quality Management
Travel Requirements
10%
Preferred Experience and Skillsnice to have
- GMP quality experience with media, biological drug substance and drug product.
- Strong Background in cGMP document review and approval.
- Strong background in cGMP compliance standards (QMS, EHS, and Site SOPs)
- Independent, self-directed strong skill sets in planning / scheduling, and time management.
- Experience with Quality Risk Management.
- Experience with Deviation Management.
- Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS.
- RCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools, including demonstrated proficiency in MPS 8-Step Problem Solving.
- Software Proficiency: Microsoft Excel, Work, PowerPoint, Teams. #SWE2026 #EBRG #VetJobs
What you'll do
- Reporting to the Quality Assurance Organization, will independently manage Shop Floor Quality Assurance team on second shift.
- Lead a Shop Floor QA team to provide end-to-end QA support for Production Support & Media, Drug Substance and Drug Product throughout the project lifecycle.
- Ensure all aspects of the Shop Floor QA proceed in compliance with cGMP, regulations, and our Company’s Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response.
- Will support and prepare Set-up Activities for SFQA First Shift (Days).
- Support Operations and the Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (e.g., CLUE and SAP).
- Support and maintain a "Safety First", " Quality Always" environment with participation in Site GEMBAs for Safety and Quality Compliance.
- Escalate and collaborate quality and compliance issues as needed through established site Tiers.
- Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area.
- Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives and metrics. Consults on an as-needed basis with next level manager on more complex decisions.
- Actively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
- Support compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).
- Consults on an as-needed basis with next level manager on more complex decisions.
Pay and benefits
$96,000 – $151,000 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
Retirement benefits including 401(k)
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
Durham, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Durham, NCWorking conditions
2nd - Evening
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
Domestic
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/11/2026
*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 - North Carolina - Durham (Old Oxford)
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$96,200.00 - $151,400.00
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 7% below the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Manager roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $96,000 | — | $151,000 |
| All US (middle half) | $119,125 | $133,250 | $152,500 |
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 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Collaboration and leadership10
- Documentation and SOPs8
- Quality systems and risk5
- Investigations and CAPA4
- Data and digital systems3
- Lab testing and methods2
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
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- 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
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized 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
- 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
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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Manager, Quality Assurance Second Shift at Merck
Applications close November 11. $96K–$151K a year, employer provided.


