Clinical Quality Assurance Manager
DEPARTMENT: Quality Assurance
LOCATION: San Diego, CA
EMPLOYMENT TYPE: Full Time, Permanent
REPORTS TO: Director, Quality Assurance
SUMMARY OF RESPONSIBILITIES:
The Clinical Quality Assurance Manager will oversee Clinical Quality Assurance (CQA) processes for daily operations at Aptose, including maintaining Aptose’s quality policies, standards, programs and continuous improvement on quality within the organization. This position will be responsible for day-to-day CQA activities in support of research projects. Additionally, the successful candidate will assist with providing QA support and training to ensure adherence with applicable regulatory requirements and company policies/procedures.
Study Team Support:
- Serve as the CQA Lead for assigned studies and participate in study team meetings as required.
- Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and act and escalate when necessary.
- Provide guidance on deviation and corrective action plans to ensure all parts of the study are conducted properly and in compliance.
- Support study-specific regulatory inspection activities at clinical investigator sites by coordinating inspection preparation.
- Coordinate and/or lead GCP training as needed.
- Perform review on documents sent to external parties.
- Lead the implementation of quality systems, processes and procedures within CQA area.
- Compile and report on trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting.
- Manage protocol deviation and safety data reviews and participate in Management Review meetings as needed.
- Proactively identify areas for improvement and collaborate with QA and other Aptose departments on continuous improvement initiatives.
Good Clinical Practice (GCP) Audit Management:
- Conduct GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures.
- Ensure timely audit conduct, reporting, review, and closeout in accordance with Aptose
- Ensure the maintenance of current and accurate audit records, including CQA audit schedules, files, and audit tracker.
QA Department Support:
- Work closely with QA management to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned.
- Support all on-site regulatory inspection activities.
- May work on other projects within QA not related to GCP and other duties as assigned.
- Bachelor’s or Master’s degree in a scientific, or life sciences discipline
- Minimum of 10 years relevant and increasingly responsible experience in the biotech / pharmaceutical Industry, specifically within GCP, clinical monitoring or equivalent and with at least 10 years in quality or compliance
- Pharmacovigilance experience is desirable
- In-depth knowledge of the drug development process (early through late stages), trial design, data and trial management procedures
- Demonstrated ability to define and implement procedures which ensure compliance to GxP and regulatory standards
- Wide-ranging experience leading regulatory authority inspections of clinical research activities, particularly in the U.S., EU and Rest of World Regions
- Pragmatic approach to issue management and risk mitigation planning
FUNCTIONAL INFRASTRUCTURE & ADDITIONAL RESPONSIBILITIES:
- Create and maintain department SOPs
- Collaborate with department members to identify process optimization / best practices and lessons learned within the functional areas that are overseen by quality.
- Monitor compliance with Aptose SOPs and guidelines, FDA regulations, and current International Conference on Harmonization – Good Clinical Practice and generate CAPAs as needed.
REQUIRED EDUCATION & WORK EXPERIENCE:
- Bachelor’s degree in Life Sciences, Master’s degree preferred
- Minimum8 years of professional work experience in clinical research in the Pharmaceutical Industry, with a minimum of 5 years’ experience in Quality Assurance or Compliance function.
- Other combinations of industry experience and training in QA audits and management may be considered.
- Experience in Hematology/Oncology (preferably non-solid tumor) clinical trials is preferred.
- In depth knowledge of industry regulations and clinical development processes with emphasis on local an international standards and regulations and associated GCP guidelines.
FUNCTIONAL/TECHNICAL KNOWLEDGE & SKILLS:
- Thorough knowledge of best practices in quality management in pharma and other relevant industries for potential application at APTOSE
- Thorough knowledge of external environment factors that impact APTOSE performance in clinical trials; understand drivers of success in clinical development
- Extensive knowledge of guidelines and regulations that affect the GCP QA programs.
- Excellent influencing, communication and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results
- Proven experience interfacing with regulatory authorities, notified third party audits and either leading or being in a lead role during regulatory inspections
- Experience with, or direct knowledge of, quality system elements such as deviations and CAPAs
- A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required
- Adeptness at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals
- Demonstrated analytical abilities and proficient planning and negotiation skills
- Communicate effectively in English, both oral and written
- Deliver on commitments
- Maintain composure
- Proactively plan and organize
- Solve problems
- Be self-aware
- Detail oriented and meticulous follow through
- Manage and improve process
- Influence and persuade
- Manage and develop people
- 25-40%, as needed
Please fill out the form below to submit your application.