Associate Director of Quality Assurance Operations (Part-Time / Contract)

Position Summary

The Associate Director of Quality Assurance Operations will help direct the management of Star Therapeutics and its affiliates quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations (GxP) by developing systems, processes and conducting audits of projects, processes, and vendors.

This is a part-time contractor role, working up to 20 hours per week.  Our offices are located in South San Francisco and we are open to onsite, remote or hybrid applicants.

Primary Responsibilities

• Provide quality oversight and management of outsourced GMP operations (CMC, CDMO, contract lab oversight)
• Independently review and approve/reject any documents that establish work instructions and/or requirements such as; policies, procedures, protocols, batch records, test methods, specifications, reprocessing and rework procedures and any changes to these documents
• Perform lot disposition of drug substance, drug product, and packaged clinical product
• Ensure the quality system records are retained and retrievable in accordance with regulatory and legal requirements.
• Review analytical data and data trending including stability data and reporting
• Ensure processes are suitable for use including implementing appropriate manufacturing in-process controls, meeting principles of validation, and ensuring that production processes are consistent and robust to meet pre-defined parameters and criteria.
• Ensure the correct labeling is used on materials and products
• Ensure investigations are conducted and root causes are identified and corrected for deviations, out-of-specification results, and product complaints
• Ensure any corrective and preventive actions from any source are communicated and implemented in a timely manner
• Assist with customer and regulatory quality and qualification audits
• Approve and monitor GMP vendors or other GMP related outsourced activities
• Assist with management review meetings by presenting quality data metrics with actionable information for continuous improvement and achievement of quality objectives
• Identify the potential need for a stock recovery, participate in the internal review of those events, and ensuring necessary activities to address the event are conducted
• Drive accountability and continuous improvement through training, SOPs, and workflows as needed to proactively improve quality, efficiency, and standardization
• Apply technical knowledge, scientific experience, and expert judgment to a broad range of difficult problems to develop effective and efficient solutions in a timely manner
• Other related duties as assigned.

Requirements

• Team-oriented individual with the ability to effectively work within a team environment.
• Works with all employee levels from executive management to line personnel
• Willingness to learn and apply new and innovative approaches.
• Excellent coaching and mentoring skills
• Excellent written and oral communication skills
• Demonstrates ability to train others
• Very organized and process oriented
• Able to work in a fast-paced environment
• Readily adaptable to changing demands
• Performs other related duties as assigned.

Education and Professional Experience

• Requires a bachelor's degree in molecular biology, biochemistry or related field
• Master's degree or higher preferred
• Minimum of 10 years of QA management experience in the biotechnology or medical device industry
• Experience in implementing quality systems for biotechnology or medical device organizations based on FDA and international standards
• Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies

Salary Range 

For candidates residing in California, this position pays $75.00 to $95.00 per hour.  This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data.  

*Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Star Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  Star is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.

Salary : $75 - $95