What are the responsibilities and job description for the Head of Quality Assurance position at BioTalent?
BioTalent are working with a pharmaceutical manufacturing organization to recruit a Head of Quality for a GMP API manufacturing site.
This is a site leadership role responsible for Quality Assurance, Quality Control, regulatory compliance, inspection readiness, batch release, and the continued development of a robust quality culture. Reporting to the Site Managing Director, you'll be the senior quality leader for the site and a key partner to both local and global leadership teams.
Key responsibilities:
• Lead and develop the QA and QC functions, building a high-performing quality organization
• Own and continuously improve the site's Quality Management System (QMS) and Quality Risk Management processes
• Act as the primary quality contact for FDA, customer, and regulatory inspections
• Lead customer audits and oversee Quality Agreements
• Ensure compliance with cGMP, 21 CFR, ICH guidelines and global quality standards
• Provide oversight of validation, qualification, change control, deviations, CAPAs and batch release activities
• Partner closely with manufacturing, technical operations and site leadership on operational excellence initiatives
• Support CMC regulatory strategy, DMF maintenance and lifecycle management activities
• Drive inspection readiness and promote a culture of compliance, accountability and continuous improvement
What we're looking for:
• BS degree in Chemistry, Life Sciences or a related discipline (Master's preferred)
• 15 years of experience within pharmaceutical, biotech or related regulated industries
• Significant quality leadership experience within API manufacturing or CDMO environments
• Strong knowledge of GMP regulations, quality systems and regulatory inspections
• Proven experience leading FDA and international health authority inspections
• Strong leadership, stakeholder management and communication skills
• Ability to influence across all levels of the organization and drive quality-focused decision making
This opportunity could be a strong fit for an experienced Head of Quality, Quality Director, Senior Director Quality, Director of Quality Operations, or Site Quality Leader looking to take ownership of quality across a clinical and commercial API manufacturing operation.
For a confidential discussion, feel free to reach out directly. #Hiring #Quality #QualityAssurance #QualityControl #API #CDMO #Pharmaceuticals #Biotech #GMP #Manufacturing #LifeSciences