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INCOG BioPharma Services · 5 months ago

Associate Director of Quality Assurance Operations

Fishers, IN

Full-time

Onsite

Lead/Staff, Director/Executive

8+ years exp

INCOG BioPharma Services is a leading CDMO focused on parenteral injectable drugs, committed to quality outcomes and customer service. The Associate Director of QA Operations will drive the organization’s Quality Mindset, manage QA operations, ensure compliance with quality standards, and lead a team to foster continuous improvement in a biopharma environment.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Lead and manage a QA Operations group across three shifts, 24/5, ensuring effective resource allocation to meet production timelines and quality standards

Ensure compliance with quality standards, cGMPs, and regulatory requirements by applying expertise to maintain inspection-readiness and serve as a key point of contact during audits

Train, mentor, and develop the QA team, focusing on gowning, contamination controls, aseptic processes, and equipment verifications to ensure a competent and engaged workforce

Prioritize and coordinate QA resources to balance production needs with product quality assurance, ensuring rigorous quality work standards and consistent product manufacture

Lead strategy and direction of the QA team to collaborate with Operations in on-the-floor batch record review, correction, and continuous improvement of quality processes

Develop and maintain room/line clearance processes for formulation, aseptic filling, and inspection/packaging areas to ensure operational efficiency and quality compliance

Manage deviation investigations as a subject matter expert, utilizing root cause analysis and risk mitigation tools to resolve issues and prevent recurrence

Ensure safety compliance by partnering with EH&S and Operations to communicate expectations, assess behaviors, and enforce SOPs, compliance, and quality guidelines

Utilize paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, etc.) to ensure data integrity and maintain accurate batch records and site policies

Stay updated on regulatory trends, leveraging continuous education, networking, and industry resources to ensure compliance with evolving regulations and best practices

Qualification

Quality AssuranceAseptic ManufacturingRegulatory ComplianceContamination ControlsRoot Cause AnalysisContinuous ImprovementData Analysis SoftwareLeadership ExperienceSelf-ManagementInterpersonal SkillsCommunication SkillsTeam Player

Required

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

Minimum of 8 years of Quality Assurance experience in biopharma aseptic manufacturing industry

Isolator-based aseptic processing experience

5+ years of experience as a people leader or supervisor

Expert level of understanding and oversight of contamination controls, drug product manufacturing processes, and output quality. Prior experience and comfort with making risk-based decisions to ensure product quality is required

Possesses excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Operations and Quality

Exceptional computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.)

Preferred

Advanced Degree

Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation

Hands-on experience with aseptic manufacturing Quality

First-hand experience participating in and/or hosting operation floor inspection tours related to Quality Assurance

Experience with building processes and procedures

Experience with Continuous improvement, Six Sigma, and/or Lean principles

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees