The Manager, Quality Systems manages the quality systems responsibilities for all people aspects, such as coaching, talent development, recruitment and performance management. This position will perform activities required to maintain an agile, efficient quality system including developing & reporting relevant metrics.
Management of site Quality system activities and services, ensuring that it is reliable and effective.
Review and approve investigations, SOPs and reports as required.
Ensure CAPAs and Change Controls are initiated and completed on time and in accordance with procedures.
Perform/Ensure satisfactory investigational and problem solving skills are in use.
Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
Able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas.
Strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Use of acceptable, applicable analytical mindset.
Able to recognize quality risks and develop contingency plans.
Able to assess, establish and implement new quality processes. Able to author resulting procedures and tools.
Able to recognize patterns in reported data and communicate strategic solutions to stakeholders cross-functionally.
Cultivate a continuous improvement culture within the site.
Able to create and maintain meaningful metrics for assigned activities.
Able to recognize trends in product data and results.
Able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes a plus.
Ensure all work performed is in compliance with required regulatory standards, conforms to company policies and SOPs.
Proactively identifies and implements improvements and lean initiatives.
Provide timely quality support to stakeholders and SMEs on projects and improvement initiatives.
Skilled in planning and organizing, building relationships, innovation management and resource allocation.
Ability to make independent and objective decisions and to work under minimal supervision with cross-functional teams and partners.
Participate in/host inspections for regulatory/internal/corporate audits.
Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
Contribute to the development of department budget and provide sound financial stewardship, management and control.
Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.
BS or MS in Life Sciences or other relevant scientific discipline with 10+ year’s industry experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or leadership experience.
In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).
Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR.
Experience in aseptic operations preferred.
Experience with regulatory inspections (e.g. FDA)
Team player, who is dynamic, motivated and excited to work with a wide range of internal experts and functions.
Excellent communications and decision-making skills, leading with initiative and ambition, and a proven ability to deliver excellence.
Collaborate and foster internal team work with other cross-functional areas and sites.
Has ability to change the thinking of or gain acceptance of others in sensitive situations.
Maintains the highest standards of ethical behavior.
Results orientated and performance driven.
May be required to work alternate shifts.