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Catalent · 2 days ago

Associate Director, Pre-Commercial Quality Assurance

Greenville, NC

Full-time

Onsite

Lead/Staff, Director/Executive

4+ years exp

Catalent is a global, high-growth company and a leading partner for the pharmaceutical industry, specializing in the development and manufacturing of new treatments. The Associate Director, Pre-Commercial Quality Assurance is responsible for providing leadership in quality assurance, ensuring compliance with cGMP, and overseeing commercial manufacturing and laboratory operations.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Act as Pre-Commercial QA SME during FDA, non-domestic and client audits and lead preparation of responses to all audit observations, particularly those related to Pre-Commercial Quality Assurance findings

Lead site cross-functional team effort to drive all pre-commercial CAPA commitments for audit responses and eQMS events to timely completion and effectiveness evaluation

Lead the team-based approach for review and verification of drug product quality in manufacturing, packaging and testing records to ensure that only compliant product is released and non-conforming materials are investigated and dispositioned appropriately

Lead in the development of a culture, and supporting systems, to drive open communication, participation and intra/inter-departmental idea-sharing to build an engaged team; advance and model company values and leadership commitments; ensure the highest levels of quality, compliance and integrity are adhered to in all interactions

Direct operations within Pre-Commercial Quality Assurance while maintaining a continuous improvement philosophy focused on improved compliance, right-first-time and process efficiency while creating an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the commercial organization

Establish and maintain active KPIs for the functional measures within Pre-Commercial Quality Assurance including periodic reporting for the KPIs; monitor and trend key Quality data for internal and external commercial supplies in support of the S&OP scorecard program

Qualification

QA/QC pharmaceutical manufacturingLeadership experienceSolid dose manufacturingAudit preparationElectronic quality management systemsContinuous improvementTeam collaborationCommunication skills

Required

PhD with at least 7 years of professional experience in QA/QC pharmaceutical manufacturing

Master's degree with at least 9 years of professional experience in QA/QC pharmaceutical manufacturing

Bachelor's degree with 10 years of professional experience in QA/QC pharmaceutical manufacturing

At least 4 years of leadership/management experience required with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives

Extensive technical skills in solid dose manufacturing and/or packaging; experience in contract manufacturing preferred

Experience leading audit preparations

Experience with electronic quality management systems such as deviation management, analytical investigations (OOS), CAPA and change control

Preferred

Experience in contract manufacturing

Benefits

152 hours of PTO + 8 paid holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)