Director of Quality Assurance at Symic Bio
Emeryville, CA, US
Symic Bio is a clinical stage biotherapeutics company developing novel compounds that target and affect the extracellular matrix (ECM), the noncellular component of tissue. The ECM plays a critical role in a wide variety of processes involved in acute and chronic indications. Symic Bio’s proprietary compounds function like proteoglycans, which are naturally occurring macromolecules that play important structural and regulatory functions in the ECM. Symic Bio currently has two clinical candidates, one in vascular injury and the other in osteoarthritis. In addition, Symic Bio has several preclinical programs in oncology, fibrosis and CNS disorders.
The Director of Quality Assurance oversees and directs the Quality Assurance function responsible for driving the development of the company’s Quality Assurance strategy and policies. Reporting to the Vice President, Regulatory Affairs and Quality, this role will manage internal Quality Assurance professional staff and/or consultants and directs and implements advancement of Symic’s Quality System.
• Drive the development of the company’s Quality Assurance strategy and policies.
• Lead Symic’s Quality Assurance operations including investigations, risk assessments/management, audits, and company wide GMP training.
• Provide Quality Assurance and compliance oversight for Symic and Symic’s suppliers and contract manufacturers.
• Direct and implement advancement of Symic’s Quality System and document hierarchy supporting Symic’s GMP operations (e.g. quality manual, SOPs).
• Provide Quality input at Product Development Team Meetings.
• Author/revise, review and approve controlled GMP documents.
• Provide GMP regulatory compliance guidance (FDA, EU & HC) for GMP operations.
• Partner and align the Quality Assurance function at Symic collaboratively with Manufacturing, Analytical, Regulatory, Clinical Development and Program Management to implement Symic’s development strategies and drive organizational success.
• Supervise Quality Assurance direct report(s) who may include internal staff and/or consultants. Ensure optimal workforce planning, retention, coaching, and performance management of staff. Mentor and manage the growth and development of direct reports.
• May present Quality Assurance plans and status to partners and senior audiences, both internally and externally.
• 8+ years of experience in a cGMP pharmaceutical or biotech company leading quality assurance. Experience with osteoarthritis or vascular disease clinical trials is a plus.
• Bachelor’s degree in science or related field; advanced degree preferred
• Knowledge, skills and experience required to provide leadership to the Quality Assurance function as it relates to GMP facilities, manufacturing, training, auditing, and testing
• In-depth knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines
• Experience in Quality oversight of outside manufacturing and/or analytical contractors including project management and auditing
• Proficient with clinical/commercial pharmaceutical programs and their global CMC requirements for IND and CTD submissions
• Ability to effectively lead the QA function and engage senior management on quality issues
• Strong project management skills with an emphasis on critical thinking and problem solving
• Outstanding written and verbal communication skills including presentation effectiveness
• Ability to coordinate & influence across various parts of the company and with multiple external stakeholders
• Committed to the values of integrity, accountability, transparency, scientific rigor and drive
• Can travel domestically and internationally, up to 25%