Senior Quality Assurance Specialist

MSD

Senior Specialist in Quality Assurance overseeing GMP contractors for clinical supply production and compliance. Supporting quality metrics and communicating with stakeholders in the pharmaceutical industry.

Posted 5/17/2026full-timeRahway • New Jersey • 🇺🇸 United StatesSenior💰 $106,200 - $167,200 per yearWebsite

About the role

Key responsibilities & impact

Operational support of Quality oversight of Third-Party Vendors within the API platform and the within TPQM team include:
Generate, negotiate, review, assess, and approve Quality Agreements between our Company's Research Labs and its contractors and cross sites and division within our Company supporting clinical supply production.
Generate, negotiate, review, and approve assessments for audit refusal and other related quality events at suppliers of GMP materials and services.
Serve as quality representative in meetings with internal and external stakeholders, including Quality Disposition and Pharmaceutical Research/Development.
Communicate clearly and effectively with internal and external stakeholders.
Collect and track Quality Agreement metrics and other operational metrics.
Act as TPQM gatekeeper and review GLOSS SOP changes, updates, and new SOPs for TPQM impact or awareness.
Collaborate with internal teams and external contractor personnel on tailgate sampling, reduced testing assessments, risk assessments, supply chain mapping, and annual report authorship.
Maintain the Quality Agreement Master List and related trackers with accuracy.
Support internal audits and inspections as needed.
Use, support, and continuously improve TPIC (Third Party Information Center) to enable TPQM workflows and operations.
Collect and track Third Party oversight related metrics.
Identify and implement process improvements, including opportunities to leverage AI tools.
Communicate with senior our Company's leadership and contractor management.
Prepare and present cross-functional management updates.
Make independent decisions and act with appropriate authority.
Identify trends and potential compliance gaps and lead issue resolution to improve quality and efficiency.
Interpret regulatory requirements and communicate them effectively across stakeholders.

Requirements

What you’ll need

A minimum of seven (5) years of relevant experience within the pharmaceutical industry OR
Advanced Degree with a minimum of five (5) years relevant experience.
Ability to independently engage with external parties.
Strong cross-functional teamwork, collaboration, influence, and negotiation skills.
Strong knowledge of EU, US, and ROW regulations and application of GMPs in an R&D environment.
Knowledge of drug development process.
Knowledge of continuous improvement methods; able to identify opportunities and implement solutions.
Experience with AI tools applications to streamline workflows and replace manual work with automation when applicable.
Strong organizational and time management skills; able to deliver well-defined projects within area of expertise.
Ability to manage conflicting priorities proactively.
Proficient with Microsoft 365 Office applications (e.g. Power Point, Word, Excel)

Benefits

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GMPQuality Agreementsaudit refusal assessmentsrisk assessmentssupply chain mappingprocess improvementsAI tools applicationsdrug development processcontinuous improvement methodsregulatory requirements

Soft Skills

cross-functional teamworkcollaborationinfluencenegotiationorganizational skillstime managementindependent decision makingcommunicationproblem resolutionability to manage conflicting priorities