Associate Director, GMP/GLP Quality Assurance

Position Summary:

Reporting to the Vice President of QA, the Associate Director, GMP Quality Assurance will help to develop and direct CMC Quality Systems and Operations supporting early phase clinical trials. This position will collaborate with senior leadership in the development, adoption, communication, and training of all employees and external contractors/vendors regarding corporate GMP/GLP quality practices/standards and setting the expectation of compliance by following strict quality standards throughout clinical product development and production.  The role will serve as a subject matter expert and resource to corporate functions for interpretation of FDA and regulatory agency regulations and guidelines, as well as corporate standards and policies related to GMP/GLP.  

Key Responsibilities:

• Provides quality operational support to ensure compliant drug development, manufacturing, product release, regulatory communication, and safety testing in support of product registration. 
• Ensures consistent application of quality standards through the development of Standard Operating Procedures (SOPs), with the preparation and maintenance of the SOPs overseen by the Quality organization.
• Plans, conducts and reports GMP/GLP audits to ensure inspection readiness both internally and with external organizations in accordance with established timelines, as necessary.
• Remain abreast of the status of quality assurance activities and identify trends, assists in the identification of potential areas of deviation; develop and/or implement policies and procedures for the resolutions of issues and complaints.
• Performs disposition activities in support of clinical product including Master and Executed Batch Record review and approvals.
• Leads in evaluations of Investigations/ OOS/ Change Controls. Supports root-cause analysis and product impact assessment for investigations.
• Reviews and manages product release and stability data.
• Assist with the FDA and regulatory agency interactions and audits. 
• Manages GMP/GLP related quality and compliance issues, ensuring appropriate CAPA (corrective and preventive action) plans are defined and implemented.
• Advises functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues.

Requirements:

• Bachelor of Science (B.S.) degree or equivalent in experience. 
• A minimum of 10 years in the biotech/pharma industry with 8 or more years in a quality role in the pharmaceutical or biotechnology industry with preference given for candidates with biologics and Cell Therapy experience.
• Demonstrated success as a Quality professional, with the ability to lead, direct and develop members in a Quality organization.
• Experience in a smaller pharma/biotech which has reached commercial stage is ideal.
• Demonstrated success in evaluating quality compliance issues in all phases of clinical development, followed by a recommendation for effective resolution.  
• Experience and a positive record of performance when presented with a health authority inspection.
• Knowledge of the pharmaceutical research and development and product development process.
• Broad knowledge of and experience applying compliance regulations.
• Familiar with quality management systems and document control systems, including database creation, utilization, and maintenance.
• Previous experience in establishing Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)) quality guidelines and FDA regulations compliance including 21 CFR Part 11 / Annex 11.
• Ability to read, analyze and interpret scientific information, reports, and technical journals.

Key Stakeholder Relationships:

• Collaborate with all levels of leaders to direct quality assurance and compliance issues to appropriate channels for investigation and resolution.
• Participate in process improvement initiatives including suggesting or evaluating change, as needed.
• Communicate with and provide updates to Senior Leadership and Compliance to ensure the business is aware of any potential risks including all identified CAPA plans.
• Managing external contract and vendor relationships to promote collaboration while ensuring supply chain reliability. 

People Leadership:

• May supervise and or direct the work of outside workers, select site staff, and or professional consultants.

Critical Skills:

• Experience building QMS and compliance programs. 
• Thorough, working knowledge of Federal Regulations and Guidance within healthcare industry.
• Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player.
• Excellent verbal and written communication skills.
• Ability to establish operational plans and strategy. Requires a balance of scientific and operational/project management and team leadership expertise.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.

The anticipated salary range for the position of Associate Director, GMP/GLP Quality Assurance based in our Menlo Park, CA office is $157,500 - $192,000.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc.  Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.