Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)

Job Description

Position Summary

The Senior Specialist, 880 Safety & Quality Compliance Operations, is responsible for establishing and sustaining a culture of safety, quality, and compliance across Building 880 FLEx Non-Sterile Operations, in partnership with the FLEx Non-Sterile Compliance, Safety & Quality Operations Lead. This role supports Building 880 in maintaining and continuously improving GMP compliance, safety performance, quality system governance, audit and inspection readiness, deviation and CAPA management, training compliance, risk management, and continuous improvement initiatives that support reliable execution of the clinical supply pipeline.

The position partners closely with Production, Tech Ops Engineering, Process Engineering, Formulators, Quality, EHS, Supply Chain, and Site Leadership to ensure safe, compliant, and reliable execution of clinical manufacturing operations while continuously improving performance. The role applies technical expertise, influence, coaching, and systems thinking to embed safety and compliance into daily operations within Building 880.

Key Responsibilities

Safety & Compliance Leadership

• Champion a strong safety culture and ensure adherence to site, corporate, and regulatory safety requirements within Building 880.
• Build collaborative working relationships and effective communication with stakeholders across manufacturing, process engineering, analytical testing, quality assurance, regulatory, and related functions.
• Support safety observations, incident investigations, risk assessments, and corrective action implementation.
• Serve as the compliance subject matter expert for GMP manufacturing operations within Building 880 Non-Sterile Operations.
• Support implementation of the clinical supply QMS through participation as a topic team member and/or subject matter expert.

Quality Systems & Inspection Readiness

• Lead and support deviations, investigations, CAPAs, change controls, and risk assessments for Building 880.
• Drive sustained audit and inspection readiness through routine compliance monitoring and self-assessments.
• Partner with Quality, EHS, Engineering, and Operations to resolve compliance risks and prevent recurrence.
• Support facility compliance, audit readiness, and continuous improvement through drafting, reviewing, and advising on deviations, investigations, change records, and related quality documents.

Training & Procedural Governance

• Oversee SOP lifecycle management and procedural compliance within the facility.
• Develop or update SOPs to ensure current practices are accurately reflected and support SOP and quality-related document approval as appropriate.
• Monitor training and qualification status to ensure workforce readiness and compliance.
• Support implementation of standardized work and best practices across non-sterile operations.

Continuous Improvement

• Analyze safety and quality metrics to identify trends and improvement opportunities.
• Apply Lean, MPS, and root cause problem-solving tools to improve operational performance and compliance outcomes.
• Promote right-first-time execution and sustainable compliance practices.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related discipline.
• 4+ years of pharmaceutical or GMP manufacturing experience.
• Experience with investigations, CAPAs, audits, and quality systems.
• Strong knowledge of cGMPs, compliance requirements, and safety programs.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Excellent verbal and written communication skills, including presentation skills.
• Demonstrated ability to manage projects and priorities to meet deliverables and timelines.
• Strong attention to detail, flexibility, and awareness of production and associated quality issues.
• Ability to work in a dynamic environment with rapidly changing needs.
• Ability to work across functions and sites, and with all levels of staff and management.

Preferred Experience and Skills

• Experience in drug product manufacture/testing.
• Oral drug product knowledge and experience.
• Knowledge of R&D or clinical supply areas and processes.
• Experience with manufacturing investigations and CAPAs.
• System knowledge of Veeva and SAP.

Success Measures

• Safety performance improvement and risk reduction.
• Audit and inspection readiness.
• Timely closure and effectiveness of CAPAs and investigations.
• Training and SOP compliance.
• Reduction in recurring deviations and compliance events.
• Sustained GMP compliance and operational excellence.

Leadership Expectations

• Lead by example and foster a Safety First and Quality Always culture.
• Drive accountability, continuous improvement, and compliance excellence across Building 880 Non-Sterile Operations.
• Operate as a trusted partner and technical resource to the Associate Director and cross-functional stakeholders.
• Demonstrate sound judgment, strong ownership, and a proactive approach to issue prevention and resolution.

#eligibleforERP

FLEx2026

#PSCS

Required Skills:

Clinical Trials Operations, Cross-Functional Collaboration, Detail-Oriented, Engineering Processes, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Operational Excellence, Performance Improvements, Process Hazard Analysis (PHA), Process Optimization, Regulatory Compliance, Regulatory Compliance Consulting, Risk Analysis, Risk Assessments, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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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.

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The salary range for this role is

$117,000.00 - $184,200.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/18/2026

• 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.