Quality Systems & Compliance Specialist
Sterling Life Sciences - San Francisco, CA

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1) Oversee day-to-day management of the CAPA Management system
2) Provide support by coordinating, managing and preparing for GxP inspections
3) Provide support to investigator site inspections conducted by global health authorities throughout Global Research and Development programs and business units
4) Develop and provide global quality/compliance services and CAPA management to company R&D business units, in collaboration with the members of the GCP/PV team and with related representatives across the R&D business units
5) Coordinate scheduling and logistics for inspection related activities
6) Collaborate with other functional areas for activities related to inspection preparation, including preparing relevant materials and conducting inspection related training
7) Participate in pre-inspection visits of investigator sites or potential 'For-Cause' audits
8) Participate in health authority inspections and ensure roles and
responsibilities have been defined and assigned for each inspection
9) Assume a role as required by the scope and nature of the inspection
10) Provide guidance as well as management to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs)
11) Assist in the preparation, conduct and management of mock inspections conducted of company's functional areas
12) Assist in developing and maintaining policies, standard operating procedures
and guidelines for preparation and conduct of inspections within company
13) Assist in preparing periodic summary reports and trend reports related to company inspections
14) Develop and maintain expertise in international GxP regulatory requirements, international PV regulatory requirements and policies, SOPs and project-specific procedures within pharmaceutical and medical device applicable to the clinical trial methodology and pharmacovigilance processes
15) Monitor trends in health authority inspection activities to proactively identify potential areas of risk for the company as part of the regulatory intelligence program
16) Coordinate Inspection Readiness (IR) modules and company management review meetings and quality council meetings
17) Provide CAPA metric update for company management review and other key management meetings (e.g. Quality Council, Audit Board) as required
18) Create, maintain and communicate meeting minutes, agenda, attendance sheet, presentations and action items from the company management review and quality council
19) Track status of all CAPAs and report overdue CAPAs to company management
20) Disseminate CAPA information as applicable to the company R&D business units
21) Implement, coordinate and continuously review CAPA system, including interface with the company management team on potential system and software program improvements
22) Assess and improve consistency, quality and timeliness of CAPA execution through implementing and maintaining effective CAPA monitoring systems and review mechanisms

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the Pharmaceuticals is strongly preferred
4) Preference will be given to people who have recent experience in Quality & Compliance

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