Clinical Quality Assurance Manager
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ:FPRX) discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
Reporting the Head of GCP QA, this position supports the Quality team, by providing GCP/GLP compliance oversight and support to the Five Prime Clinical Development (CD) therapeutic areas and clinical study teams. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines and Five Prime Standard Operating Procedures (SOPs) for the conduct of clinical studies.
In this role, the Clinical Quality Assurance Manager will utilize a risk-based strategy to prioritize GCP QA support for clinical trial activities, identify and escalate compliance issues, enable pro-active decision-making,
and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition, the Clinical Quality Assurance Manager will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.
The Clinical Quality Assurance Manager will actively contribute to the development and implementation of Policy/Standard Operating Process /Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution within the Five Prime Clinical Development organization. The responsibilities include and not limited to the following:
- Provide quality leadership and direction to Five Prime Clinical Development (CD) stakeholders on GCP-related activities/issues and act as GCP expert/consultant for GCP QA colleagues
- Act as GCP QA member of clinical study teams for relevant Therapeutic Areas.
- Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity in order to identify: priority studies, compliance metrics for tracking, high-risk Service Providers, and key GCP QA activities (i.e. protocol review, service provider evaluations, inspection readiness).
- Conduct external GCP audits of clinical/pharmacovigilance service providers, CROs, and
- Conduct Investigator site audits for applicable clinical trials.
- Conduct internal process audits for clinical and pharmacovigilance functions.
- Identify and escalate significant compliance issues to GCP QA and relevant leadership, including
the assessment of serious breaches.
- Participate as member of clinical study execution teams for assigned Therapeutic
- Establish relationship with CRO Quality Team members for the ongoing review of quality
and compliance issues.
- Participate in Service Provider evaluations as a Subject Matter Expert (SME) as needed.
- Present GCP training to CD functions based on identified needs.
- Facilitate the presentation and interpretation of audit and inspection trends and metrics.
- Identify and anticipate trends in quality issues and collaborate with department
management to ensure risk-managed solutions are implemented in a timely fashion
- Maintain high level of expertise in international GCP regulations and internal policies
and procedures that may impact drug development.
- Provide regular updates to senior management functions and participate in the
resolution of quality issues.
- Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or policy-related training (as required)
- Provide support and guidance during and following internal audits and external regulatory
inspections (as required)
- Support CD Inspection Readiness program and make recommendations for its continuous
- Participate on quality and compliance initiatives, as assigned
- Bachelor’s degree in scientific, health sciences or quality-related field.
- Minimum of 8 years in a pharmaceutical drug development in a GCP related discipline.
- Expert knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA,
MHRA) and ICH Guidelines.
- Previous experience managing quality and GCP compliance issues.
- Certified Quality Auditor Experience with cross-functional stakeholder management.
- Good knowledge of the drug development processes.
- Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
- Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
- Ability to influence people at different levels and negotiate cross-functionally in matrix organization to resolve conflicts.
- Ability to build and sustain meaningful relationships with business stakeholders and partners.
- Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance and escalations
- Strong project management skills including team leadership, consultative facilitation, risk analysis, and project planning.
- Highly self-motivated, well-organized, confident, possess a solution-oriented mindset and able to develop innovative solutions to issues.
- Strong computer literacy in MS Word, Excel, Project, Visio and PowerPoint.
FivePrime is an equal opportunity employer committed to a diverse workforce. FivePrime makes employment
decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability
All your information will be kept confidential according to EEO guidelines.