QA Operations Manager, PCU Lead

About the role

Quality assurance and operations

• Develop annual quality assurance objectives for E&M/Distribution manufacturing aligned with organizational strategy.
• Ensure production complies with GMP, regulatory requirements, and company quality standards; identify, track, and mitigate quality risks.
• Oversee batch release for further manufacturing and timely, compliant final disposition of completed batches.
• Lead investigations into quality issues, deviations, and out-of-specification results, including risk assessment and product-impact evaluation.
• Collaborate with production teams and audit processes to maintain quality standards and identify potential issues.
• Manage and resolve manufacturing quality issues in a timely and effective manner.
• Establish and monitor quality KPIs; drive continuous improvement in quality and operational efficiency.
• Evaluate technologies, tools, and methods to improve quality assurance processes and promote a quality culture.
• Lead hiring, training, coaching, and performance evaluation for the quality assurance team; ensure staff are qualified and trained on current standards.
• Participate in regulatory inspections and audits and ensure valid site manufacturing licenses and product permissions.

Education and experience

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or a related field is required; an advanced degree is preferred.
• At least 8 years of experience in quality roles is required; pharmaceutical industry experience is preferred.
• Experience or in-depth knowledge of GMP regulations and guidelines is preferred.
• Previous management experience is preferred.
• Strong understanding of pharmaceutical manufacturing processes and associated quality control methods.
• Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
• Proven team leadership and coaching ability, effective communication, and ability to work with stakeholders and cross-functional manufacturing teams.

Benefits

• The employer describes career development opportunities, a rewards package, and health and wellbeing benefits.