The Site Head of Quality ensures the integrity of pharmaceutical products by maintaining compliance with cGMP regulations and industry standards. They drive Quality Operations Procedures and work closely with stakeholders to align Quality Systems with Operations and Supply Chain. This role also ensures adherence to Global Quality Standards, adapts to regulatory changes, and promotes best practices across locations.
Establishes effective communication networks among plant personnel, management, staff, and regulators.
Manages staffing, training, motivation, and team communication.
Develops and executes departmental objectives aligned with site goals.
Makes all site-related quality decisions.
Leads management review meetings and contributes to GXP-compliant Quality Operations Policies.
Supports the implementation of Quality Operations Policies
Hosts regulatory inspections and addresses inquiries.
Monitors compliance in manufacturing and packaging processes.
Stays current on regulations and Good Manufacturing Practices.
Ensures adherence to quality manufacturing standards and prepares facilities for audits.
Acts as Management Representative, overseeing the effectiveness of the quality system.
Supports Compliance Intelligence to identify and respond to global trends.
Qualifications
Bachelor's Degree in Chemistry or a related science required; advanced degree preferred.
15+ years in Quality Assurance/Compliance within the pharmaceutical or biotech industry
Proven experience leading FDA inspections.
Deep understanding of global GXP requirements.
Strong knowledge of pharmaceutical manufacturing processes.
Proficient in laboratory testing procedures and instruments.