Director, Global GMP QA
Structure Therapeutics
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
POSITION SUMMARY
Reporting to Executive Director of GMP Quality Assurance is responsible for the strategic development and operational management of Structure Therapeutic’s quality assurance program and is accountable for the execution and administration of the GMP Quality Operations to support CMC operations and preclinical studies in accordance with FDA, ICH, EMA, China NMPA GMP regulations and guidelines and industry standards. The scope of this role includes ensuring Good Manufacturing Processes (GMP) and Good Laboratory Practices (GLP) compliance and quality systems at Structure Therapeutics and its vendors. This position requires expertise in current GMP/GLP relevant regulations. This role is accountable for ensuring that vendors and laboratories are compliant with global regulations, prepared for potential Regulatory Audits and Inspections and that the appropriate processes, systems, and activities are in place and performed to protect product quality and data integrity.
The ideal candidate will have extensive experience in leading GMP Quality Assurance activities and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GMP compliance during clinical development and commercialization of drug candidates. QA GMP team will be accountable for all aspects of product quality throughout development, both internally and in collaboration with CMDOs and testing laboratories. The ideal candidate will have a proven track record of providing quality assurance support for regulatory submissions of quality-related sections resulting in worldwide marketing approvals for drug products.
- Preference is for local candidates, and we are moving to a 4-day work week/in the SSF QC office.
- If remote, you will be required to work in SSF QC office one week a month.
Essential Duties and Responsibilities
- Lead the QA GMP team in managing all GMP/GLP related QA activities
- Lead the QA GMP/GLP team in development, implementation, and management of Structure Therapeutic’s GMP/GLP quality operations and policies, SOPs, QA processes and procedures
- Ensure good communication and decision making at the appropriate levels for quality GMP/GLP related topics
- Support the planning and conduct of internal and external audits
- Write and review of CMC quality related sections for regulatory submissions.
- Support the internal and regulatory agency on GMP/GLP related inspections
- Lead GMP/GLP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations
- Ensure Technical Operations and vendor activities are compliant with cGMP, FDA, ICH, EMA, NMPA regulations and guidelines and industry standards
- Stay abreast of industry developments – forthcoming regulations, guidance, best practices, etc., training, and mentoring staff on global GMP/GLP regulations and guidance
- Identify quality improvement needs and opportunities and assure that appropriate personnel address the issues. Assure corrective actions are implemented
- Keep informed to Company’s Executive Leadership Team on the implications and risks related to key Quality issues and important strategic decisions, keeping all posted, on a timely basis
Core Competencies, Knowledge, and Skill Requirements
- Advanced degree, ideally in life sciences related field with at least 10+ years of experience in positions of substantial management responsibility within Quality Assurance
- Strong knowledge of small molecule drug substance and oral solid dosage forms manufacturing preferred
- Strong working knowledge of global GMP/GLP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct
- Skilled at preparing, negotiating and managing phase-appropriate quality agreements with Structure Therapeutic’s GMP/GLP vendors
- Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation
- Proven experience in Quality oversight and managing CDMO relationships
- Proven track record in establishing a quality organization and managing GMP Quality staff
- Demonstrated success supporting cross-functional teams and managing direct reports
- Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific and operations leaders and staff
- Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections
- Experience with documentation systems, document review and auditing responsibilities
- Demonstrated ability in setting successful quality strategies and building and leading the function
- Knowledge of relevant regulations, including FDA, EMEA, ICH
- Ability to think strategically and translate into action
- Available to travel if/when needed
Communication and Interpersonal Skills
- Small company / pre-commercial to commercialization stage experience desirable
- Strong collaboration and cross-functional team participation skills
- Preference for applying a solutions-oriented mindset and approach to resolving complex quality issues
- Effective leader of others and ability to mentor/develop team members
- High self-awareness and commitment to iterative learning and development
- Effective communicator, verbal and written, strong interpersonal skills
- Accuracy and attention to details
The target salary range for this full-time role is $200,000 - $253,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.