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 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:

Bachelors degree in a scientific or engineering discipline (e.g. Biology Chemistry Biochemistry Chemical Engineering) with a minimum of 7 years relevant experience OR Masters 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:

Preferred Skills:

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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 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

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.

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