Senior Specialist Quality Assurance

MSD

1d • $106,200 - $167,200 • Hybrid

About The Position

Quality Assurance protects patient rights and well-being, supports compliance with global regulatory requirements through effective processes and procedures, and provides independent assurance of high-quality data and clinical supplies. Within the API Platform TPQM team in GDQ, the Senior Specialist, Quality Assurance acts as the quality representative, overseeing contractors involved in GMP activities, including the generation, negotiation, and review of Business Continuation Memos and Quality Agreements that support clinical supply production on behalf of the company. Key responsibilities include: 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. In addition to the job specific responsibilities discussed above, the Senior Specialist is expected to independently execute key activities as listed below. Key activities this position would encompass: • 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

• 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.
• Bachelor’s degree in engineering, Biology, Chemistry or related field.
• Adaptability
• Audits Compliance
• Continuous Process Improvement
• Data Analysis
• Detail-Oriented
• Deviation Management
• Drug Development
• Due Diligence
• Employee Training Programs
• GMP Auditing
• GMP Compliance
• Internal Auditing
• Interpersonal Relationships
• Manufacturing Processes
• Manufacturing Quality Control
• Microsoft Word
• Negotiation
• Pharmaceutical Management
• Pharmaceutical Research
• Process Improvements
• Quality Assurance (QA)
• Quality Assurance Systems
• Quality Risk Management
• Regulatory Requirements

Nice To Haves

• 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)

Responsibilities

• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior