DIRECTOR TO EXECUTIVE DIRECTOR - QUALITY ASSURANCE
JOB TITLE: Director to Executive Director, Quality Assurance (QA)
LOCATION: San Diego, CA; On-Site; Full Time
Redeployment was created to match great people with great Life Science companies! We are seeking an experienced Director to Executive Director, Quality Assurance to lead the quality management function at our client's innovative biotechnology company dedicated to advancing cancer therapeutics.
This role is central to establishing and implementing a comprehensive quality management system (QMS) to ensure compliance with global GxP regulations (FDA, EU, etc.) and inspection readiness. The successful candidate will be responsible for overseeing quality assurance across all GxP activities, vendor qualifications, and audits, as well as driving a culture of quality excellence and continuous improvement. This position requires extensive expertise in cGMP manufacturing and prior success in supporting regulatory inspections.
RESPONSIBILITIES:
Leadership and Management:
Build and lead the Quality Assurance team, promoting a culture of accountability and continuous improvement.
Develop strategic quality plans that align with company goals and regulatory standards.
Collaborate cross-functionally to ensure quality standards are met across all stages of the product lifecycle.
Quality Systems and Oversight:
Oversee the development, implementation, and monitoring of QMS in compliance with GMP regulations.
Establish quality metrics and KPIs to assess QMS performance and maintain regulatory readiness.
Ensure that cGMP manufacturing processes and documentation adhere to global regulatory standards.
Conduct regular audits of GxP vendors and oversee quality agreements with CDMOs/CROs.
Review and approve critical manufacturing documents, including batch records, method validation reports, API and DP release documents, and CTM labeling, packaging, and distribution records.
Lead the GxP Training Program, ensuring that all personnel receive comprehensive training on quality systems and GMP compliance.
Proactively identify and address quality risks, leading investigations into quality issues, deviations, and non-conformances.
Implement corrective and preventive actions (CAPAs) to resolve quality events and ensure ongoing compliance.
Risk Management:
Develop and deliver GMP training programs to ensure compliance and maintain staff knowledge on quality standards.
Keep the organization informed on industry trends, regulatory updates, and best practices.
Training and Development:
Develop and deliver GMP training programs to ensure compliance and maintain staff knowledge on quality standards.
Keep the organization informed on industry trends, regulatory updates, and best practices.
Continuous Improvement:
Drive initiatives for continuous improvement to enhance product quality, operational efficiency, and regulatory compliance.
Track and monitor KPIs to measure and improve quality performance across all operations.
QUALIFICATIONS:
Education: Bachelor's degree in Chemistry, Life Sciences, or a related field; advanced degree preferred.
Experience: At least 15 years of experience in Quality Assurance within GMP manufacturing environments, ideally in biotech or pharmaceutical companies.
Regulatory Knowledge: Expertise in cGMP regulations, quality management systems, and industry best practices. Familiarity with GCP, GLP, and pharmacovigilance regulations is beneficial.
Leadership and Collaboration: Strong communication and interpersonal skills with a demonstrated ability to collaborate across departments and with external vendors (e.g., CDMOs, CROs).
Regulatory Inspection Experience: Proven experience in successfully hosting regulatory inspections (FDA, EMA, etc.) is preferred.
Analytical and Organizational Skills: Highly organized with strong critical thinking abilities, attention to detail, and accuracy.
CULTURAL COMPETENCIES:
Quality-Focused: Demonstrates an unwavering commitment to quality and compliance.
Collaborative Leader: Leads with integrity, fostering a culture of teamwork and accountability.
Detail-Oriented & Strategic: Balances attention to detail with strategic oversight of quality systems and regulatory requirements.
Continuous Learner: Stays up-to-date on industry regulations and best practices, sharing knowledge within the team.
BENEFITS:
$190K - $280K; DOE
Medical Insurance: Comprehensive medical plan options, including HMO and PPO plans.
Dental Insurance: PPO dental plan with coverage for preventive, basic, and major services.
Vision Insurance: Vision plan with benefits for exams, lenses, and frames.
Prescription Drug Coverage: Tiered prescription drug coverage with mail-order options.
Flexible Spending Accounts (FSA): Healthcare and Dependent Care FSAs for eligible expenses.
Life and AD&D Insurance: Basic life and AD&D insurance with additional voluntary options.
Short and Long-Term Disability Insurance: Income protection through short-term and long-term disability coverage.
Employee Assistance Program (EAP): Confidential support and counseling services for employees and dependents.
About The Company
Our client is dedicated to transforming cancer treatment through innovative drug development. With a highly skilled management team and a focus on rigorous scientific research, they are advancing novel therapies to make a meaningful impact in cancer care.
Redeployment is defined as "the process of moving people to a different place or using them in a more effective way." We are a recruiting and executive search firm that uses our size and unique background to provide a personalized hiring experience to startups as they raise money, expand their business, and grow their team. With a focus in the biotech space, our expertise is getting to know and understand company culture, ensuring the RIGHT prospects are connected to the RIGHT companies. Reach out today!