INCOG BioPharma Services Careers

Description

Reporting to the Associate Director, Quality Assurance – Batch Review and Disposition, the Quality Assurance Manager is the site owner for the oversight, progression, and on-time closure of batch-impacting deviations and other batch-gating quality system records managed in Veeva QMS. This is an individual contributor position with no direct reports; the Manager leads through influence, partnership, and clear accountability across Formulation/Filling, Inspection/Packaging, MS&T, Quality Assurance, Quality Control, Engineering/Facilities, Validation, and Supply Chain.

The Manager provides end-to-end oversight of the deviation lifecycle—from initiation and triage to deviation writer assignment, investigation, review and approvals, through closure—ensuring each record is completed on time and to quality standard and in accordance to procedure. The Manager coordinates and drives cross-functional deviation teams, sequences work against batch disposition due dates, removes barriers, and escalates promptly when timelines or investigation quality are at risk.

This position is also a change agent. The Manager is expected to identify friction in the current deviation process, design and implement better ways of working within Veeva QMS, and raise the overall speed and quality of investigations so that batches are dispositioned on time for our clients and their patients. The Manager owns deviation and turnaround-time metrics and KPIs tied to batch disposition performance, and presents that data to site leadership, clients, and inspectors with clarity and command of the underlying records.

The Quality Assurance Manager will demonstrate excellent written and oral communication skills, strong technical writing and investigation review capability, and the ability to hold peers and senior stakeholders accountable to commitments in a constructive, collaborative manner. The Manager will thrive in a team environment while also working autonomously with sound scientific judgment and risk-based decision making.

Scope and Authority: The Quality Assurance Manager owns delivery, prioritization, and escalation of batch-impacting quality event closure and supports product impact and disposition assessments.

Essential Job Functions:

•      Own oversight of batch-impacting deviations in Veeva QMS from initiation through closure, maintaining real-time visibility of record status, ownership, aging, and due dates against committed batch disposition dates.

•      Drive cross-functional deviation teams to on-time completion across Formulation/Filling, Inspection/Packaging, MS&T, Quality Assurance, Quality Control, Engineering/Facilities, Validation, and Supply Chain, without direct reporting authority, by setting clear expectations, sequencing tasks, and following through to closure.

•      Manage the full deviation lifecycle cadence – initiation, triage, writer assignment, investigation and data gathering, product impact assessment, CAPA identification, review, approvals, and closure – ensuring each stage advances within procedural timeframes.

•      Track all batch-gating QMS records (deviations, related change controls, CAPAs, and other quality events required for disposition) tied to open lots, and maintain a prioritized, disposition-driven work queue shared with Manufacturing, Quality, and Project Management.

•      Chair recurring deviation and batch-gating review meetings to align on priorities, confirm commitment dates, resolve barriers, and drive decisions that keep records moving toward closure.

•      Escalate promptly and objectively when investigation timelines, data availability, resourcing, or record quality place a batch disposition commitment at risk, providing options and recommended paths forward to the Associate Director and site leadership.

•      Review deviation content for technical and compliance quality for problem statement clarity, event timeline, evidence gathered, root cause methodology and conclusion, product quality and SISPQ impact rationale, batch and lot extent-of-condition, and adequacy of corrective and preventive actions.

•      Coach deviation writers and investigation owners on investigation methodology, GMP-appropriate technical writing, data-supported conclusions, and inspection-ready documentation practices.

•      Support batch disposition decisions by ensuring all batch-impacting quality events for a lot are closed, or appropriately assessed and documented, in advance of the disposition date.

•      Own deviation metrics and KPIs, including on-time closure rate, cycle time by lifecycle stage, aging and backlog, right-first-time review, extension frequency and rationale, and deviation turnaround time as it relates to batch disposition performance.

•      Compile, analyze, and present deviation performance data to site leadership, quality management review, clients, and regulatory inspectors, articulating trends, drivers, and improvement actions with command of the underlying records.

•      Act as a change agent for deviation process improvement, identifying process friction, designing and implementing improved workflows, templates, triage criteria, and Veeva QMS configuration or reporting enhancements that increase speed without reducing quality.

•      Author, revise, and maintain procedures, work instructions, job aids, and training content supporting deviation management, triage, investigation, and batch-gating record oversight.

•      Partner with the client-facing organization to communicate deviation status, investigation conclusions, and disposition timing to clients in a clear, factual, and timely manner.

•      Apply risk-based principles and trending analysis to identify repeat events, site-wide improvement opportunities, and preventive actions across products, equipment, processes, and areas.

Special Job Requirements:

•      Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology, Engineering, etc.).

•      Minimum of 3 years of Quality Assurance experience in pharmaceutical or biopharmaceutical manufacturing, with at least 3 years focused on deviation/quality event management and investigations preferred.

•      Demonstrated experience owning or driving deviation and quality event closure to committed timelines in a cGMP manufacturing environment.

•      Hands-on proficiency with an electronic QMS; direct Veeva Vault QMS experience strongly preferred, including workflow ownership, task routing, and report/dashboard creation.

•      Strong working knowledge of cGMP requirements and regulatory expectations for deviation investigation, root cause determination, product impact assessment, and CAPA (21 CFR 210/211, EudraLex Annex 1, ICH Q9 and Q10).

•      Proficiency with structured investigation and root cause methodologies (e.g., 5 Whys, Fishbone/Ishikawa, Is/Is-Not, Fault Tree, Kepner-Tregoe or equivalent).

•      Excellent technical writing and document review skills, with the ability to produce and assess inspection-ready investigation narratives supported by objective evidence.

•      Demonstrated ability to influence, align, and drive accountability across functions without direct reporting authority.

•      Strong project management and prioritization skills, with the ability to manage a high volume of concurrent records against firm customer delivery and batch disposition commitments.

•      Proficiency building and presenting quality metrics and KPIs, including data compilation, trending, and executive and client-facing communication.

•      Excellent analytical and problem-solving skills with demonstrated ability to make risk-based quality decisions under time pressure.

•      Exceptional attention to detail and the ability to identify potential quality issues that may not be immediately obvious.

Additional Preferences:

•      Hands-on experience with aseptic manufacturing Quality.

•      CDMO or multi-client manufacturing experience, including client-facing communication of investigation outcomes.

•      Experience supporting regulatory inspections and client audits as a deviation or quality system subject matter expert.

•      Experience with building processes and procedures in a new or rapidly scaling organization.

•      Experience with Continuous Improvement, Six Sigma, and/or Lean principles; certification a plus.

•      Experience with batch record review, batch disposition support, or product release processes.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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