Quality Assurance Unit Manager I (FDA, GMP, GLP) - SRI International

Overview

SRI's Biosciences Division develops transformative approaches and platforms for challenging therapeutic problems. We conduct basic and translational research, have the breadth - and depth - to deliver the latest in biomedical research through technology development. Our researchers have a rich legacy of collaboration with government agencies and industry partners that improve health outcomes and well-being around the world. SRI Biosciences projects range from high-impact, early-stage research to drug co-development with pharmaceutical and biotech companies.  Regulated work conducted by SRI staff includes safety testing, clinical manufacturing and Phase I-IV clinical trials.  SRI, working with its partners and collaborators, has advanced over 225 drugs into clinical trials, and at least 25 have achieved market approval.

The Quality Assurance Unit (QAU) Manager leads the SRI Biosciences Division’s Quality efforts. Primary responsibility is to provide quality assessment to Good Laboratory Practice (GLP) / current Good manufacturing Practice (cGMP) / Quality System Regulation (QSR) programs. This is accomplished through proactive inspections and retrospective data / report audits to ensure that all work is conducted in accordance with FDA regulations, international regulations, protocols, Standard Operating Procedures (SOPs), and corporate policies.

Ensures that personnel, methods, corporate policies and standard operating procedures comply with: FDA requirements for Good Laboratory Practices (GLP) for conducting scientific research, current Good Manufacturing Practice (cGMP), Quality System Regulation (QSR), Good Clinical Practices (GCP), and 21 CFR Part 11. Performs internal GLP, cGMP, QSR, GCP and Part 11 audits as well as external audits of laboratory facilities, protocols and reports. Provides quality guidance to project teams.

Serves as advisor and spokesperson to management and represents Quality Assurance function on major matters pertaining to its policies, plans, and objectives. Often performs in a Quality leadership role. Applies wide-ranging experience with quality concepts and SRI objectives to resolve complex issues in creative and effective ways. Manages cross-functional teams focusing on internal or external client projects. Contributes to development of new concepts, techniques, and standards.

Participates with other senior managers to establish strategic plans and objectives. Is involved in issues requiring analysis of situations or data and in-depth evaluation of variable factors. Makes final decisions on administrative or operational matters. Works on complex issues for which analysis of situations or data requires an in-depth knowledge of SRI. Networks with key contacts outside own area of expertise.

This job will be based in Menlo Park, CA.  It is a flexibly hybrid role where time can be spent working from home, but there will also be requirements to come into our facility in Menlo Park for specific times.

Responsibilities

• Supervises QAU staff of 1-2 individuals; set goals, conduct performance evaluations, assist in setting compensation.  Assign responsibilities for QAU activities as described below.
• Performs GLP, cGMP, QSR, GCP (Coordinate with external GCP auditors as required for compliance in clinical trials)  and 21 CFR Part 11 audits/inspections.  
• Maintains the Master Schedule.
• Performs planned and unplanned audits for compliance to applicable government regulations and to company policies and procedures; re-audits of deficient matters and corrective actions, as needed and required. Documents audit results in written audit reports that are distributed and reviewed by appropriate management.  
• Monitors program performance after implementation to prevent re-occurrence of program operating problems and ensure efficiency of operation. Trends findings to provide feedback to SRI departments. Serves as consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government regulations. Provides compliance expertise to the organization as required.
• Audits vendors and suppliers. Maintains files containing audit reports and audit responses, and pertinent corrective action follow-up for audits. Escorts outside auditors representing government agencies, clients/sponsors or those requested by management at all times during their audit. Report findings of outside auditors to management. Reviews audit responses and assists with required training in response to audit. Provides advice and guidance to less experience Quality System Auditors.            
• Performs compliance training (GLP, cGMP and other, as appropriate).    
• Tracks regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Maintains regulatory licenses (e.g., Establishment Registration, Drug Manufacturing License) and files.           
• Supervises Equipment Calibration Database activities.    
• Archives studies to the SRI Records Center.         
• Performs Document Control activities.   
• Trains personnel on proper SOP formatting & writing. Assists in interviewing, hiring, and evaluating staff for key positions.

Qualifications

Required:  

• BA/BS or in related technical field of study or significant equivalent experience and at least 5 years of quality management experience in the pharmaceutical or diagnostic sciences.
• Knowledge and Understanding of 21 CFR 58 and/or 21 CFR Parts 210/211.
• Ability to communicate clearly and effectively.
• Detail oriented.
• Strong problem-solving and analytical skills.
• Must be able to meet deadlines.
• Ability to work as part of a team and build collaborative relationships.
• Must have a strong work ethic, be dependable, honest and responsible.
• Demonstrates the ability to succeed within a team-based environment.
• Self-motivated and enthusiastic with ability to initiate action.
• Demonstrates a positive and professional demeanor throughout Quality Assurance and all SRI Biosciences departments.

Preferred:

• Experience with FDA audits.
• Demonstrated success with professional communications.
• Experience with approaching situations as a quick study:  understands information quickly and easily, comes up with more efficient processes within an environment of institutionalized processes, and an ambition for logical change.

The salary range is: $109,000-$135,000/ annually. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program.

SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.