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- Salary $290,000 - $350,000
- LocationSan Francisco, California
- Employment type Permanent
- Discipline
- Job descriptionReporting to the Senior Vice President of Global Regulatory Affairs and Quality Assurance, this position will serve as an in-house champion on GxP compliance as well as establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day). If remote, you will be required to work in the SSF office one week/month. ESSENTIAL DUTIES AND RESPONSIBILITIES Strategic Leadership: Develop and execute a global quality strategy aligned with corporate goals and regulatory requirements Drive a culture of quality excellence, compliance, and continuous improvement across the organization Act as a key member of the clinical leadership team, providing strategic insights on quality-related matters impacting clinical development, regulatory submissions, and commercialization Compliance and Oversight: Ensure compliance with global regulatory standards, including FDA, EMA, and ICH guidelines Oversee the design, implementation, and maintenance of Quality Management Systems (QMS)to support clinical development and manufacturing activities Lead preparation for, and responses to, regulatory inspections, audits, and interactions Operational Excellence: Establish and monitor quality metrics to identify trends, assess risks, and implement proactive solutions Lead the QA oversight of clinical trial activities, including Good Clinical Practice (GCP) compliance audits of sites, vendors, and internal systems Oversee Good Manufacturing Practice (GMP) activities for drug manufacturing, ensuring product quality and supply chain integrity Team Leadership and Development: Build, manage, and mentor a high-performing global QA team Promote collaboration across Clinical, Regulatory, and Operations functions to achieve quality goals efficiently Ensure appropriate resources and training are in place to maintain compliance and support corporate growth REQUIREMENTS Education Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred) Experience Minimum of 15 years of experience in Quality Assurance, with at least 5 years in a senior leadership role in the pharmaceutical, biotech, or medical device industry Proven track record in global QA strategy development and implementation Comprehensive knowledge of GCP, GMP, GLP, and global regulatory requirements Leadership Skills Strong ability to influence and lead cross-functional teams Highly diplomatic Flexible thinking and pragmatism Experience developing and mentoring high-performing teams in a global environment Technical Skills Expertise in regulatory inspections and audits Strong analytical and problem-solving skills, with a proactive and results-oriented mindset Expert knowledge of GMP, ICH/GCP, and GLP FDA regulatory requirements; previous experience in APAC preferred Familiarity with discovery data integrity policies and quality assurance a plus Have strong technical skills, both functional and non-functional, manual and automation, ideally in a continuous delivery environment Demonstrated success in making informed decisions for the department The ability to prioritize and handle multiple activities daily yet flexibility and responsiveness to frequently shifting priorities Demonstrated ability to positively integrate into a team environment (US, APAC) Strong sense of ethics and honesty Collaborative in partnerships with Project Teams and individual team members Be an advocate of QA, Continuous Improvement, and industry-recognized Best Practices Excellent knowledge of Risk Management, Risk Identification, and Risk-based Testing Excellent communication, influencing, and negotiation skills to get management buy-in on ideas and concepts Ability to communicate with all levels of management and peers within the organization Ability to build, implement, and direct quality assurance principles and maintain the quality of delivery