Head of Quality/ Quality Manager

Head of Quality/ Quality Manager

Head of Quality | Quality Manager | Contract-to-Hire | Onsite in Petaluma, CA Pay Rate: $65$85 per hour Industry: Biotechnology and Medical Devices

About the Company: Client is an innovative biotechnology and medical device company developing advanced antimicrobial technologies for medical and consumer applications. The company is focused on translating cutting-edge scientific discoveries into solutions that advance infection prevention, patient safety, and public health.

The Opportunity: Experienced, hands-on Head of Quality to lead and build the company's Quality function in a fast-paced, growth-stage environment. This is a high-impact leadership opportunity for a quality professional with deep experience across pharmaceutical, medical device, and ideally combination product environments.

Make a meaningful impact: Help advance innovative antimicrobial technologies designed to address critical infection-prevention needs. Own the Quality function: Serve as the senior Quality authority with broad, end-to-end responsibility. Build something important: Establish the systems, processes, and culture needed to support future growth. Work at the intersection of science and commercialization: Collaborate across biotechnology, pharmaceutical, and medical device disciplines. Join a high-growth organization: Contribute directly to the company's next stage of development and operational scale.

The Head of Quality will own the end-to-end Quality organization, including Quality Assurance, Quality Control, Microbiology, Validation, supplier quality, and regulatory quality activities. This leader will establish, strengthen, and scale a compliant Quality Management System while translating operational processes into clear, practical, and inspection-ready documentation. Ideal candidate is an autonomous and proactive quality leader who can operate effectively in an environment with evolving processes and limited infrastructure. This individual will provide strategic direction while remaining highly involved in day-to-day execution.

Key Responsibilities: Lead the Quality function across Quality Assurance, Quality Control, Microbiology, Validation, and regulatory quality activities. Establish the Quality vision, strategy, roadmap, and operating model in alignment with patient safety, regulatory expectations, and business objectives. Build, remediate, and scale a comprehensive GMP-compliant Quality Management System for pharmaceutical, medical device, and combination product operations. Develop, revise, and harmonize quality documentation, including: Standard operating procedures, Work instructions, Forms and templates, Policies, Validation protocols and reports, Quality records, etc.. Translate operational processes into clear, compliant, and traceable documentation suitable for FDA inspections and GxP-regulated operations. Ensure compliance with applicable FDA regulations and standards, including: 21 CFR Parts 210 and 211, 21 CFR Part 820, ISO 13485 & SO 14971, QMSR requirements and other applicable GxP and data integrity expectations. Serve as the Quality authority during FDA inspections, regulatory audits, customer audits, and other external assessments. Lead audit preparation, execution, response development, and follow-up activities. Oversee investigations, deviations, nonconformances, complaints, CAPAs, change controls, and other quality events. Develop and implement risk-based quality and validation strategies. Establish and maintain a centralized validation program, including equipment, process, cleaning, analytical, computerized system, and GxP systems validation as applicable. Provide oversight of validation activities, including IQ, OQ, PQ, process validation, and validation lifecycle management. Oversee batch review and release, stability programs, environmental monitoring, microbiology, and other quality operations. Establish supplier qualification, supplier quality oversight, and supplier audit programs. Lead the implementation, optimization, or transition of electronic Quality Management Systems. Support the evaluation and potential future implementation of eQMS platforms such as Veeva. Improve documentation efficiency, simplify validation strategies, and streamline quality processes without compromising compliance. Build, mentor, and lead a high-performing Quality team. Communicate quality risks, priorities, and recommendations to executive leadership. Take ownership of significant Quality responsibilities and provide practical, risk-based solutions in a resource-constrained environment.

Required Qualifications Bachelor's degree in science, engineering, pharmaceutical sciences, quality, or a related field; advanced degree preferred. Significant experience leading a Quality organization or serving in an equivalent senior Quality leadership role. Direct ownership of multiple Quality functions, such as QA, QC, Microbiology, Validation, and supplier quality. Experience in both pharmaceutical and medical device environments. Experience with drug, device, or combination product development and manufacturing. Strong knowledge of FDA-regulated GMP and medical device quality systems. Deep understanding of applicable regulations and standards, including: 21 CFR Parts 210 and 211, 21 CFR Part 820, ISO 13485, ISO 14971, QMSR and GxP requirements. Experience leading or supporting FDA inspections and other regulatory audits. Demonstrated success building, remediating, or scaling a compliant QMS. Strong technical expertise in: Investigations and root-cause analysis, CAPA management, Change control, Risk management, Validation, Supplier qualification and auditing, Product release, Quality documentation, Data integrity. Experience developing SOPs, work instructions, forms, validation documentation, and other inspection-ready quality records. Experience with GxP systems validation and the ability to establish a centralized validation framework. Proven ability to lead teams, establish accountability, and influence cross-functional stakeholders. Strong written and verbal communication skills, including the ability to communicate effectively with executive leadership. Ability to make independent, risk-based Quality decisions in a fast-moving environment.

Preferred Qualifications: Experience in an early-stage, startup, or growth-stage biotechnology or medical device company. Combination product Quality experience. Experience with Phase 2 IND product manufacturing and elevated cGMP requirements. Experience implementing, transitioning, or integrating an electronic QMS. Familiarity with QMSR transition requirements. Experience with Veeva or other electronic Quality Management Systems. Familiarity with Salesforce or similar CRM systems. Familiarity with BigCommerce or other e-commerce platforms. Experience developing Quality systems in preparation for increased regulatory, operational, or investor scrutiny.

Work Environment: This is an onsite position in Petaluma, California. The successful candidate must be comfortable working hands-on in a dynamic environment where processes and infrastructure are still being developed, 3-4 days a week onsite at the worksite are required.

Position Details: Position Title: Head of Quality. Employment Type: Contract-to-hire. Work Arrangement: Onsite. Location: Petaluma, CA. Pay Rate: $65$85 per hour, with an anticipated target rate of approximately $76 per hour. Benefits available during the Kelly Engineering contract period; additional company compensation and incentive opportunities available upon conversion.