Associate Director, Compliance Operations —Investigation Writer

Job Description

We are seeking an experienced, detail-oriented Associate Director to join the Biologics Pilot Plant (BPP) Operations team within Vaccines and Advanced Biotechnologies Process Research and Development (VAXPR&D). In this role you will lead, author, document, and drive formal investigations of process deviations, non-conformances, and incidents to determine root causes and ensure compliance with regulatory requirements and internal standards. You will partner closely with process development, manufacturing, and quality colleagues to implement corrective and preventative actions, support investigation governance, and improve operational robustness across upstream and downstream pilot operations.

The position will be temporarily based in West Point, PA for approximately 18 months (up to 24 months) to support business needs. After this period, the role is intended to relocate to Rahway, NJ. Applicants should be comfortable with this planned geographic transition. In Rahway, the position will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

Primary Responsibilities:

• Lead end-to-end deviation and incident investigations across manufacturing operations — initiate investigations, interview personnel, review batch records/logs/outputs, gather evidence, and draft final reports.
• Prepare, edit, and finalize deviation reports, non-conformance records, QA investigation documents, and technical write-ups suitable for internal review and regulatory submission.
• Perform thorough root cause analyses using formal tools (5 Whys, Fishbone/Ishikawa, Fault Tree) and document rationale and evidence supporting conclusions.
• Develop, document, and track Corrective and Preventive Actions (CAPAs); ensure effectiveness checks are planned, executed, and documented.
• Ensure investigations meet internal timelines and regulatory expectations (e.g., timely initiation, risk assessment, and escalation; adherence to standard SOP timeframes).
• Assess the need for product disposition recommendations (e.g., quarantine release, rework, scrap) and prepare clear justification for Quality Control decisions.
• Collaborate closely with cross-functional teams including Manufacturing, Process Development, Quality, Analytical, and Safety to obtain technical input and implement remedial actions.
• Maintain and update entries in the Quality Management System (QMS) and deviation tracking tools; ensure investigation documentation is complete, traceable, and audit-ready.
• Provide independent technical review and editorial oversight of investigation documentation prepared by site staff to ensure consistency, clarity, technical accuracy, and regulatory defensibility.
• Participate in or lead deviation trend analysis and periodic management reviews; identify systemic issues and recommend process or systems improvements.
• Train and coach site personnel on effective investigation and deviation-reporting practices, including interview techniques and evidence collection.
• Support regulatory inspections and internal audits as a subject-matter contributor for investigations and corrective action topics.

· May oversee site training function, as required, upon transfer to Rahway, NJ.

· Travel: Up to 25% travel is required for trainings, key face-to-face meetings, and on-site investigations, primarily to West Point for a duration of 18-24 months.

Education Minimum Requirements:

Bachelor’s degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biochemistry, Chemical Engineering) with a minimum of 7 years’ relevant experience OR Master’s degree with a minimum of 5 years’ relevant experience in pharmaceutical/biologics/vaccine manufacturing, QA/QC, or a related regulated environment.

 

Required Experience and Skills:

· GMP manufacturing of biologics, or vaccines, and/or process development activities.

· Demonstrated experience writing and closing deviations, investigations, or CAPAs in a cGMP-regulated environment (biologics, pharmaceuticals, vaccines, or medical devices).

· Strong technical writing and editing skills with the ability to convert complex technical information into clear, succinct, and defensible reports.

· Solid knowledge of cGMP, Quality Systems, and regulatory expectations (FDA, EMA, ICH) for deviation handling and CAPA.

· Proficiency with Quality Management Systems (electronic QMS preferred), deviation tracking tools, and common office software.

·Strong investigative skills, including interviewing techniques, evidence collection, and data-driven root cause analysis.

· Excellent interpersonal skills and ability to work cross-functionally; comfortable asking probing questions of manufacturing and lab personnel.

· High attention to detail, organizational skills, and ability to manage multiple investigations concurrently while meeting deadlines.

· Sound judgment and the ability to escalate appropriately when product quality or patient safety concerns arise.

 

Preferred Experience and Skills:

• Prior experience as a Deviation Writer, QA Investigator, Quality Control Technical Writer, or CAPA Lead.
• Formal training or certification in root cause analysis, CAPA, or quality tools (e.g., Six Sigma, RCA certification).
• Experience supporting regulatory inspections and preparing responses related to investigations and CAPA.
• Experience with trend analysis and metrics for deviation/CAPA effectiveness and continuous improvement initiatives.
• Demonstrated ability to influence in a matrixed organization and lead problem resolution teams.
• Experience drafting technical content for regulatory submissions or inspection packages.

• Demonstrates Ownership & Accountability: takes responsibility for timely, high-quality investigation outputs and follow-through on CAPA effectiveness.
• Execution Excellence: delivers accurate, audit-ready documentation with consistent attention to procedural and regulatory requirements.
• Decision Making: analyzes technical data and makes defensible recommendations about product disposition and corrective actions.
• Collaboration: builds productive relationships with operational teams and quality partners to resolve issues and improve systems.

Required Skills:

Adaptability, Adaptability, Biopharmaceuticals, Biopharmaceutics, CAPA Processes, Chemical Biology, Chemical Engineering, Clinical Supplies Management, Clinical Trials, Customer-Focused, Data-Driven Decision Making, Detail-Oriented, Drug Product Development, Estimation and Planning, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Quality Control, Medical Devices, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Quality Management, Regulatory Inspections, Safety Compliance {+ 3 more}

Preferred Skills:

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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:

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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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

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:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/15/2026

*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.