Senior Specialist Quality Assurance

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.

Education Minimum Requirement:

• Bachelor’s degree in engineering, Biology, Chemistry or related field.

Required Experience and Skills:

• 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.

Preferred Experience and Skills:

• 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)

Required Skills:

Adaptability, 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 {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

The salary range for this role is

$106,200.00 - $167,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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.