GCP Compliance Manager

GCP Compliance Manager

The GCP Compliance Manager, Cancer Biomarker and Development (CBD), will support CBD labs in achieving Good Clinical Practice (GCP) compliance and implementing continual improvements to maintain compliance. This role supports compliant implementation of new processes, equipment, and software systems, validation of existing equipment, and maintenance of compliance on all validated systems. The candidate will generate, compile, and execute validation documents, work with end users to document protocols, and manage controlled temperature units while ensuring appropriate documentation for GxP standards. Responsibilities include authoring, reviewing, and routing documents required for validation (e.g., SOPs, URSs) to support quality systems and presenting to leadership teams on lab GxP status.

Accountabilities:

• Manage database of validation projects for new equipment and for revalidation of existing equipment, schedule and coordinate cross-functional equipment/system validation activities.
• Generate validation documents, execute protocols, conduct temperature mapping, document data and write reports, generate traceability matrices.
• Coordinate with Quality Management to author, review and route System Operating Procedures (SOP) and Work Instructions (WI) among other procedural and regulatory documents.
• Produce and manage other documents as needed in support of quality systems.
• Facilitate project team meetings as required to review with equipment owners the status of each project and ensure completion of each defined goal for the project.
• Ensure equipment and areas are labeled with appropriate validation information in accordance with GxP regulations.
• Ensure that all validation documents are appropriately completed, stored and archived in accordance with SOPs and regulations.
• Perform triennial periodic reviews for the CSV equipment’s, CTU management and alert system maintenance and re-validation of the CTU units as required or minimum every 5 years.
• Submit work orders for equipment (calibrations, service requests).
• Support compliance of individual functional areas as assigned.
• Sustain functional expertise of enterprise-wide quality systems in support of the organization.
• Maintain compliant records in support of GLP and laboratory GCP.
• Maintain constant collaborative interactions with co-workers across functional groups and departments. Support and/or co-ordinate the maintenance of the CSV equipment for any on-demand and annual maintenance requirements.
• Initiate and support the process of decommissioning of equipment through change controls in EQV, when needed.
• Generate and execute computer system validation documents like Requirement Specifications, Risk Assessments, Traceability Matrices, Validation Plans, Validation Summary Reports, Installation Qualifications, System Acceptance Testing, and User Acceptance Testing, along with completing periodic reviews.
• Lead all aspects of validation efforts relating to computer systems, and coordinate with other functions, e.g., IT-quality management, as required.
• Assist with regular departmental audits and inspections.
• Manage systems and equipment changes through documented change management processes.
• Responsible for documenting activities following Good Documentation Practices (GDP).
• Review contractor validation documentation.
• Perform scheduling of activities for software validation activities.

Essential Skills/Experience:

• Bachelor's degree, preferably in the biological sciences
• 1+ year of direct experience supporting compliance and/or validation activities
• Functional knowledge of GxP/ICH regulatory requirement
• Excellent organizational skills, attention to detail, and documentation practices
• Strong communication and interpersonal skills
• Proficient in use of relevant computer programs (Microsoft Office, Excel and MS Project)

Desirable Skills/Experience:

• Master's degree, preferably in the biological sciences
• 1+ year of experience using automated IHC staining platforms
• Biopharmaceutical industry, hospital or academic experience

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest Oncology pipelines in the industry, there are many opportunities to work with new drugs and help discover what's next. We draw on diverse knowledge from across the business to tackle the toughest medical challenges. Empowered by our collective wisdom, we take smart risks, challenge norms, and learn from failures. Our commitment to patients drives us to innovate constantly.

Join us in making a meaningful difference in patients' lives by applying today!

The annual base pay for this position ranges from $113,244.80 - 169,867.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.