Interim Quality Assurance Site Head
Location: Southern California
Work Arrangement: Onsite, five days per week
Duration: Approximately 3–9 months
Start: Immediate
Schedule: Full-time onsite
Position Overview
We are seeking an experienced Interim Quality Assurance Site Head to provide Director-level Quality leadership for a GMP contract testing laboratory supporting biotechnology and pharmaceutical clients.
The consultant will lead the daily activities of the Quality Assurance organization supporting analytical operations and provide oversight of cGMP quality systems, data integrity, investigations and CAPA, laboratory quality activities, and inspection readiness. This individual will also serve as a key member of site leadership, partnering with operational leaders to manage quality and compliance risks while supporting continued business growth.
This is a hands-on interim leadership assignment requiring a seasoned Quality professional who can effectively manage the QA organization, make scientifically sound and risk-based quality decisions, and serve as the primary Quality representative for clients and regulatory authorities.
Key Responsibilities
- Lead and direct daily Quality Assurance activities supporting GMP analytical laboratory operations.
- Provide cGMP compliance expertise and leadership across site operations.
- Lead Quality Management Review activities and appropriately escalate significant quality and compliance risks.
- Ensure quality decisions are scientifically sound and based on appropriate risk-management principles, including ICH Q9.
- Provide Quality oversight of data integrity, computerized systems, and electronic records compliance.
- Oversee change controls, deviations, OOS/OOT investigations, CAPAs, and related quality-system activities.
- Support or conduct customer complaint investigations as required.
- Provide Quality oversight for analytical method qualification, validation, verification, and transfer activities.
- Coordinate GMP and Quality training activities.
- Monitor quality metrics, identify trends, and drive continuous improvement.
- Lead regulatory inspection readiness and serve as the primary Quality representative during regulatory inspections.
- Serve as the primary Quality Assurance representative for clients and lead client audits.
- Provide Quality oversight of suppliers, contractors, and service providers.
- Lead, develop, and manage Quality Assurance personnel, including coaching, performance management, succession planning, and employee development.
- Partner with site leadership to support operational priorities and continued business growth.
- Promote a strong quality culture and effective accountability throughout the organization.
Required Qualifications
- Minimum 15 years of experience within pharmaceutical, biotechnology, CDMO, or GMP contract testing laboratory environments.
- At least 5 years of Quality leadership experience with direct management responsibility.
- Bachelor's degree or equivalent in a scientific discipline.
- Demonstrated experience successfully hosting and leading regulatory inspections and client audits.
- Demonstrated experience implementing and maintaining Data Integrity programs within GMP-regulated laboratories.
- Advanced knowledge of cGMP requirements, FDA regulations, and ICH guidelines applicable to contract laboratory operations.
- Advanced knowledge of USP, European Pharmacopoeia, and other applicable compendial methods and procedures.
- Strong understanding of laboratory testing methodologies, including wet chemistry, chromatography, spectrometry, calorimetry, and microbiology.
- Advanced root-cause investigation and problem-solving capabilities, including experience with 5 Whys and/or other appropriate root-cause investigation tools.
- Strong knowledge of laboratory computerized systems, including LIMS, chromatography data systems, electronic document management systems, and applicable electronic records and electronic signature requirements.
- Strong project management, organizational, communication, and decision-making capabilities.
- Demonstrated ability to lead teams, establish accountability, manage competing priorities, and drive programs from concept through execution.
- Ability to work onsite five days per week in Southern California.
Preferred Qualifications
- Advanced degree in a scientific discipline.
- ASQ certification.
Work Arrangement
This is a full-time, onsite interim leadership assignment requiring presence at the Southern California facility five days per week. The engagement is anticipated to last approximately 3–9 months while the organization assesses its longer-term Quality leadership needs and future organizational structure.
Ideal Candidate
The ideal consultant is a seasoned Quality Assurance leader with extensive experience in GMP-regulated pharmaceutical, biotechnology, CDMO, or contract testing laboratory operations. This individual will combine strong cGMP and laboratory quality systems expertise with demonstrated people leadership, data integrity experience, and a successful track record leading regulatory inspections and client audits. The consultant must be capable of quickly assuming ownership of the site QA function and providing credible, hands-on Quality leadership across analytical operations.