Site Head of Quality
Location: Raleigh, North Carolina
Compensation: $195,000 - $215,000 base salary + 15% annual bonus opportunity
Relocation Assistance: Provided
Reports To: Director, Quality Technical Operations (Solid Line)
Dotted Line: Site Director
Position Summary
We are seeking an experienced and strategic Site Head of Quality to lead all Quality Assurance and Quality Control operations for our commercial sterile manufacturing facility in Raleigh, North Carolina.
This executive-level leader will be responsible for ensuring full compliance with current Good Manufacturing Practices (cGMP), global quality standards, and applicable regulatory requirements while fostering a strong culture of quality throughout the organization. The Site Head of Quality will provide leadership for Quality Operations supporting the manufacturing, testing, packaging, and warehousing of sterile commercial pharmaceutical products and serve as the primary quality representative for regulatory inspections and corporate quality initiatives.
The successful candidate will be a collaborative leader with deep expertise in sterile pharmaceutical manufacturing, regulatory compliance, and quality systems who can influence cross-functional teams and drive continuous improvement across the site.
Key Responsibilities
Champion and cultivate a proactive quality culture aligned with cGMP requirements and global quality standards.
Provide strategic leadership for all Quality Assurance and Quality Control functions, including Quality Systems, Quality Operations, and Microbiology.
Ensure quality systems remain compliant, effective, and continuously improved.
Build, develop, coach, and mentor high-performing quality teams while ensuring appropriate staffing and training.
Establish and monitor key quality performance indicators, communicating results to site leadership and Corporate Quality while driving corrective and preventive actions.
Partner with the Site Leadership Team to execute the site's operational vision and business objectives.
Serve as the primary liaison between the Raleigh site and Corporate Quality, participating in cross-site quality forums and global quality leadership initiatives.
Lead site readiness for regulatory inspections, customer audits, and internal audits.
Act as the primary contact during regulatory inspections and oversee all agency communications and follow-up activities.
Identify, assess, and escalate critical quality issues to Corporate Quality while ensuring timely resolution.
Ensure all quality documentation complies with applicable regulatory requirements and company policies.
Drive corporate quality improvement initiatives by sharing best practices across manufacturing sites.
Establish measurable quality goals aligned with business objectives.
Ensure performance management processes are effectively implemented across the Quality organization.
Perform additional responsibilities as assigned.
Qualifications
Required
Bachelor's degree in Biology, Chemistry, Microbiology, Engineering, or a related scientific discipline; Master's degree preferred.
12-15 years of progressive leadership experience within pharmaceutical manufacturing, including sterile products.
Minimum of 7 years of leadership experience in Quality Assurance and/or Quality Control, ideally with responsibility for both functions.
Extensive knowledge of global pharmaceutical regulations, including FDA, EMA, ANVISA, and MFDS requirements.
Expert knowledge of cGMP regulations and pharmaceutical quality systems.
Demonstrated success leading FDA inspections and regulatory interactions.
Proven experience developing and improving quality systems within a commercial manufacturing environment.
Exceptional leadership, coaching, and organizational development skills.
Strong analytical and problem-solving capabilities with the ability to make sound, data-driven decisions.
Excellent written, verbal, and interpersonal communication skills.
Ability to influence cross-functional teams and build collaborative relationships across the organization.
Preferred
Master's degree in a scientific or engineering discipline.
Experience supporting Finance, Supply Chain, Operational Excellence, or Health, Safety & Environment (HSE) initiatives.
3-5 years of direct experience in sterile pharmaceutical manufacturing operations.
Leadership Competencies
The successful candidate will demonstrate:
Strategic leadership and executive presence
Strong coaching and mentoring abilities
Continuous improvement mindset
Excellent change management skills
Outstanding problem-solving and decision-making capabilities
Effective communication and stakeholder management
Ability to build high-performing, accountable teams
Commitment to integrity, compliance, and quality excellence
Physical & Working Conditions
Ability to lift up to 35 pounds without assistance.
Occasional work in manufacturing environments requiring personal protective equipment (PPE).
Combination of office and manufacturing floor responsibilities.
Frequent computer use.
Domestic and international travel as business needs require.
Organizational Scope
Reports directly to the Director, Quality Technical Operations with a dotted-line relationship to the Site Director .
Leads a team of approximately 5-7 direct reports across Quality Assurance and Quality Control.
Responsible for quality oversight of the Raleigh manufacturing site while collaborating closely with global manufacturing sites and corporate quality organizations.
Responsible for developing and managing the annual Quality department budget.
Compensation & Benefits
Base Salary: $195,000 - $215,000
Annual Bonus: 15% target incentive opportunity
Relocation assistance provided
Comprehensive benefits package
Opportunity to lead quality strategy at a growing sterile pharmaceutical manufacturing site while partnering with global quality leadership.
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