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New · posted Nov 5

Merck · Pharmaceuticals

Manager, Quality Assurance Second Shift

  • Durham, NC
  • On-site
  • Full-time
  • Manager
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EmploymentFull-time
DeadlineCloses Nov 11, 2026

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

Preferred Skillsnice to have

Current Employees apply HERE

Current Contingent Workers apply HERE

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 provided
How this compares

Additional 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, NC

Working 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:

EEOC Know Your Rights

EEOC GINA Supplement​

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

$96,000 to $151,000 a year

Manager roles in the US14 roles publishing pay

Middle half $119,125 to $152,500, median $133,250
Annual base pay
Annual base payLowMedianHigh
This role$96,000—$151,000
All US$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.

  1. Earlier

    Associate & Specialist

    Often: Associate · Associate II, Quality Operations

    $85K median34 open
  2. One step back

    Senior & Principal

    Often: QA Specialist · QA Release Senior Quality Reviewer

    $96K median16 open
  3. This role

    Manager

    Often: Manager, Quality Assurance Operations · Manager, Quality Operations

    $133K median16 open
  4. Next step

    Director

    Often: Associate Director, GMP Operational Quality · Associate Director, GCP Operational Quality

    $200K median20 open
  5. Later

    VP & Executive

    Often: Quality Site Head

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 compliance: 11 linesLab testing and methods: 2 linesDocumentation and SOPs: 8 linesInvestigations and CAPA: 4 linesQuality systems and risk: 5 linesData and digital systems: 3 linesCollaboration and leadership: 10 linesGMPLab testingDocumentationInvestigationsQuality systemsData systemsTeamwork
  • 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.

Company 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%
See all 40 Merck roles

More roles at Merck

All 40 Merck roles

Similar Quality Operations & Batch Release roles elsewhere

Manager, Quality Assurance Second Shift at Merck

Applications close November 11. $96K–$151K a year, employer provided.

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