MANAGER, QUALITY OPERATIONS

Role Title.
Manager, Quality Operations Reporting to.
Director, Quality Operations Roles and Responsibilities.
Ensure Quality Operations / Quality Assurance in compliance with applicable regulations and policies, Standards, including FDA, Safety and Environment.
 Aid in development of site Quality strategy and impactful G&Os with inputs from the Supply Chain Quality organization, franchise, region, and other partners.
 Responsible and champion for successful development, deployment and implementation of strategies and associated policies, procedures, programs, and initiatives that deliver quality, compliance, cost and/or operating benefit to the supply chain.
 Champion an E2E approach and collaborate with global franchise Supply Chain Quality organization and other functions to provide insights, benchmark, and drive quality improvement actions and plans.
 Support site quality strategic plan, annual goals, BP, LRFP, JU, NU and all business and financial cycle related activities within the site.
 Monitor site Quality dashboards and finalize other critical metrics regularly.
Provide site Quality program/project portfolio updates such as JJPS, TQI, capacity model and be accountable for progress of site quality assurance capital investments, CIPs, and other pivotal initiatives.
Utilize cost control initiatives to reduce expenses.
 Provide leadership within site Quality Organization by mentoring and supporting developmental opportunities to members of the Quality team via initiatives related to transformations and/or other J&J initiatives.
Provide guidance and support for Quality, Supply Chain and Enterprise related initiatives.
 Provide energy for innovative and transformational changes to the site in alignment with other parallel strategies by the site management.
 Act as a change agent to promote use of tools and approaches to redesign current processes for the vision and strategy of the future including shaping the Quality organization structure, providing agile processes, and building capable site teams.
 Demonstrate strong leadership and ability to engage and guide the site members of Quality Organization on quality improvement culture and new thinking, attitudes, and behaviors.
 Partner with individuals and teams to develop and implement innovative solutions and continuous improvements with proven and measurable business results.
 Exercise the highest level of integrity in the tasks performed in a timely and prompt manner.
 Cultivate a constructive Diversity, Equity & Inclusive (DE&I) working environment.
 Responsible for communicating business related issues or opportunities to next management level.
 For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Qualifications Qualifications.
Bachelor's degree is required in Pharmaceutical Sciences / Postgraduate in Science or related discipline preferred.
A minimum of 8 years responsibility and experience in a highly regulated environment is required including a broad and deep working knowledge of the operating functions of quality and compliance, supply chain, material supply and material handling and control, product manufacturing and product packaging.
Minimum 5 years of experience in Supervisory or Managerial cadre.
Preferably trained Internal Auditor as per ISO-.
 An understanding and application of cGMP and internal/external Health Authority compliance expectations is required.
 Excellent communication, collaboration, and influencing skills across multiple functions and levels within the organization is required.
 Prior experience with regulatory inspections is desirable.
 Prior experience with project management, Lean, Six Sigma, Operational Excellence, change management training and/or certification is desirable.