Facilities GMP/GXP Lead
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.
Facilities GMP/GXP Lead
AbbVie Stemcentrx is adding to its Facilities team a Facilities GMP/GXP Lead to manage compliance activities for the department, as well as oversee certain facility and engineering operations. The ideal candidate will implement best practices to streamline compliance operations within the facility department, as well as oversee ongoing facility activities and supervise facility engineers and technicians. This individual performs documentation reviews thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls. Supports GMP compliance with time spent in the GMP environment on a regular basis, working with the quality and manufacturing team as it relates to their facility needs. Makes decisions independently, and investigates, and resolves complex technical issues using problem-solving skills. The candidate will also oversee facilities assets and operations, working closely with the Senior Manager of Facilities and Engineering.
The position is responsible for providing a wide range of critical support for facilities services, such as maintenance and GMP support. The focus of the position will be coordination, planning, scheduling, and communication of non GxP and GxP work orders across multiple buildings, as well as identifying, solving, and communicating facilities issues. The successful candidate will also work with procurement to assist in renewing equipment service contracts with mechanical, electrical, and plumbing maintenance vendors. The lead will also closely with IT to define scope of work for capital expansion projects and site integration.
Key Responsibilities Include:
- Coordinate and oversee the maintenance of facility and scientific equipment, including directing Maintenance and Engineering personnel in the development and execution of preventative maintenance programs, calibrations, certifications, and repair response activities.
- Accountable for GMP deliverables as it relates to facilities - building or equipment
- Work with function heads and leadership to assure needs are met, as it relates to building/facility engineering, GMP compliance, maintenance and calibration
- Manage the addition of new capital assets, from budgetary approvals and site planning to installation and close-out accounting, directing the Capital Concierge and external vendors.
- Manage and oversee the implementation of monitoring systems for building and equipment by working with landlord engineering and internal maintenance teams to respond to any alarms.
- Assist Senior Manager in expansion and renovation construction management, taking lead as project manager for select building, compliance, or customer projects
- Work with EHS Specialist to ensure safety and compliance of the facility through implementation and adherence to appropriate procedures, especially in regard to planning and new capital projects.
- B.S. in in a Life Sciences discipline or at least 3 to 4 years of quality-related or facilities compliance experience, within an ISO or GXP environment
- Previous experience leading a small team and supervising and guiding technical staff
- Experience in HVAC systems and correlation to GMP functionality is required
- Proven ability to manage multiple tasks, prepare metrics and meet deadlines.
- Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.
- Experience with supplier quality systems and performing internal audits
- • Solid understanding of GMP utility systems and manufacturing process equipment.
- Strong working knowledge of GMP compliance requirements related to maintenance operations.
- Computer proficiency on CAD, Word, Excel, Power Point, Outlook, and Microsoft Project preferred.
- • Previous experience with CMMS (Computerized Maintenance Management System) and BMS (Building Automation Systems) is a plus.
- • Experience working within QSI Released Documents, Engineering Change Request, Corrective action and NCMR databases
- Experience working with IT / technology projects, such as migration and infrastructure
- Experience with GMP/QC Equipment qualification validation
- Adept at working with function heads and senior leadership on facility needs and compliance
- Experience in project/program management. PMP or PMI is an added plus.