Head of Quality
Pionyr Immunotherapeutics, Inc. a growing and well-funded South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced Head of Quality to play an integral role in moving our discovery research efforts into the clinic. We are seeking an experienced and motivated Quality leader who will be responsible for implementing and driving Pionyr’s quality strategy, systems, training programs, identifying and assessing regulatory and quality risks and ensuring adherence to global regulations and company policies.
The Head of Quality will provide hands-on leadership for managing the day-to-day Quality Assurance (QA) activities for Pionyr as the company moves from preclinical to cGMP manufacturing and GCP regulatory submissions into the clinic. The right candidate will have in depth quality and analytical experience, regulatory knowledge, and ability to prioritize and be comfortable in executing daily operational tasks while setting and executing the Quality function strategy.
Specific Responsibilities Include (but not limited to):
- Develops global quality strategies and systems to ensure Pionyr is compliant with relevant regulations, in a development phase-appropriate manner, from preclinical to clinical and ultimately commercial development
- Provides overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical; determines applicable quality standards and regulations and provides guidance and quality oversight to ensure ongoing compliance.
- Establishes strong working relationships and alignment with external manufacturers to support production of quality drug products that meet our company quality standards and government regulations.
- Ensures CDMOs are adequately resourced and operating in compliance with cGMP and adhering to the principles of worldwide guidelines such as ICH
- Ensures CROs are adequately resourced and operating in compliance with GCP requirements.
- Educates/trains company employees on quality matters to ensure compliance with requirements
- Responsible for Pionyr’s manufacturing quality systems execution and management of deviations, CAPA, change control and risk management activities, ensuring adherence to applicable GMP regulations and Pionyr policies and procedures
- Contributes to the preparation of CMC and Clinical sections for regulatory submissions
- Collaborates with Process Sciences and Analytical Development and/or outside contract labs to ensure seamless method transfer and validation
- Proactively identifies quality & regulatory issues and provides solutions to keep development plan on time, while maintaining the highest quality
- Maintains knowledge of the current regulatory & quality environment, identifies risks, interprets and communicates relevant issues to project team members and senior management
- Responsible for management of site document control system and records management
- Ensures appropriate quality criteria incorporated in selection, implementation or upgrading of electronic systems used to support GXP related activities
- Develops and oversees the execution of site internal audit program (self-audit); host corporate and external audits, including regulatory inspections
- Establishes and effectively manages Pionyr’s Quality Systems & Compliance programs annual operating budgets
- Oversees the approval of all specifications, procedures and formulas that impact the strength, quality, purity, and efficacy of manufactured and contract-manufactured products
- Works collaboratively across departments and with vendors to ensure timely batch release of clinical trial materials
- Develops and implements quality metrics to drive continuous improvement
- An advanced degree in the Life Sciences, a PhD or PharmD, with at least 15 years’ GMP and/or GCP QA leadership experience in the biopharmaceutical, or biotechnology industries. An equivalent mix of education and experience will be considered
- Working knowledge of GLP, GCP and cGMP and their applications in a stage-appropriate manner
- Experience with oversight of the quality function within a company that outsources activities such as manufacturing, clinical trial, diagnostics and analytical work
- Understanding and knowledge of regulatory/quality requirements for biologic and/or antibody-based therapies
- In-depth knowledge of both US (CFR and GMP) and EMEA (Eudralex) regulations
- ISO 9001 certified preferred but not required
- Proven ability to implement world-wide quality strategies
- Self-starter who works with a sense of urgency and is a team player
- Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment
- Ability to proactively identify challenges, and implement appropriate courses of action
- Strong knowledge of cGMP (FDA, EU and ICH) requirements, FDA/EU regulatory guidelines, validation practices, Quality and Compliance principles
- Established track record of successful BLA/approvals
- Experience in managing a manufacturing network from drug substance to drug product and cold chain management
- Working knowledge of risk management tools
- Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management as well as with external partners
- Must be able to innovate, analyze and solve problems with minimal supervision and strong attention to detail.
- Willingness to travel as necessary, consistent with program needs
How to Apply
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to email@example.com.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.