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

• Bachelors 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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The salary range for this role is

$117000.00 - $184200.00

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 employees 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 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

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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:

08/31/2026

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