The Manager/Sr Manager, Compliance and Quality Systems is a strategic role with a broad cross functional interface responsible for providing a globally aligned GxP document and records management framework within Beam and will work with all sites and functions to manage, direct, and support a standardized process for managing GxP documents and records through their lifecycle (creation through archive). This role will act as a leader in the NC site Quality organization while developing and executing Beam’s Global Quality System activities. The position is critical for Beam in support of broader organization moving products through the clinical pipeline to commercial launch and growth.
The Manager/Sr Manager, Quality Systems will have responsibility to ensure Quality foundational processes and systems are optimized and executed appropriately to support GxP operations. This includes developing and directing document management policy and procedures for the organization, as well as, supporting the regular implementation of fully validated system upgrades and enhancements. This shall include management and oversight of controlled documentation and records management. In addition, the position will support global deployment of electronic workflows for QMS roadmap including but not limited to CAPA, Deviation and change management. The position will coordinate collection and reporting of Key Performance Indicator data in support of Global and site level management reviews.
The Manager/Sr Manager, Quality Systems is a full-time position and is expected to be an on-site resource at Beam, NC with remote work some percentage of time depending on current work assignments. This position would also support Beam Cambridge, with up to 25% potential travel.
- Manages a global team responsible for the document management business processes.
- As part of the Global Quality System organization, the individual will act as a leader in the NC site Quality organization in close collaboration with GMP Quality.
- Writes and implements changes to Standard Operating Procedures as applicable.
- Facilitate and oversee the new hire training programs; creating engaging content to support training as needed.
- Manage Quality foundational processes and support GxP owners with implementation and improvement.
- Support Deviation Management, Change Control and Continuous Improvement. Facilitate weekly meetings and escalate any issues as applicable.
- Support training related to Deviation, CAPAs, Continuous Improvements, Change Control and Quality Docs.
- Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records.
- Performs the appropriate QA review/approval of SOPs, SOP-related documents, and Work Instructions.
- Partners with Cambridge site to ensure alignment of records archival with global policies and SOPs.
- Leads and supports understanding and adoption of risk-based approaches and decision making.
- Drives digitalization through incorporation of E-Systems into site document archival processes and backups.
- Act as the Inspection Readiness Lead.
- Partner with all levels of the business to ensure strategic learning and organizational plan development.
- The individual will align site standards and systems with global standards.
- Lead the site’s records management (i.e., Document Management review, reconciliation, and archival process).
- Ensure that Quality Systems are operating in a way to provide appropriate operations support.
- Participate in developing the overall strategy and details on the enabling electronic platform(s) used by the Quality Systems processes.
- Role is responsible for development, implementation, and execution of compliance driven KPIs and metrics, and establishment of site Quality Management review.
- Provide technical expertise for quality decisions as needed.
- Provide leadership, guidance, and direction to staff and across Beam’s various departments consistent with cGxP.
- Mentor/coach staff in development opportunities.
- Perform mid-year and end-of-year performance reviews, as applicable.
- Evaluate continuous improvement options for the NC Quality Systems and lead NC implementation.
- Supports other members of the Quality Team and organization in aspects not related to the core responsibilities of the Quality Systems area.
- Promotes change adoption regarding Quality Systems.
Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.
- Bachelor’s degree in related discipline or 10+ years’ or commensurate experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
- Experience in leading individuals associated with Quality Systems as part of overall background is preferred.
- Understanding of worldwide requirements of GMP and Quality Systems for Clinical and Commercial products.
- Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
- Experience interacting with regulatory health authorities at pre- and post-approval inspection.
- Established expertise and training in GxP systems.
- Experience with Veeva Vault Documentation, Training and QMS applications preferred.
- Solid knowledge of global regulations and standards.
- Ability to evaluate Quality Systems and drive value added enhancements.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high-quality work at all times.
- Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
- Ability working cross-functionally and developing/delivering trainings to all levels of the business