Head of GMP Manufacturing Operation is responsible for leading GMP manufacturing operations. He/ She will lead cross functional team(s) to consistently deliver high quality clinical products consistent to annual budget, volumes, yields, and clinical manufacturing plan in compliance with global regulatory requirements. For approximately the next two years. The role will focus on leading GMP team to deliver on the GMP capital project and plant operation thereafter. Key accountabilities will be ensuring facility is constructed, qualified, validated and operated to meet safety, quality, performance, regulatory, schedule, and budget requirements. He/She will partner with other functions including Quality, Engineering, Supply Chain, EHS and Technical Services/ Validation to drive continuous improvement in safety, quality, fulfilment, capacity, cost, and project execution. The facility resource management is primarily based heavily on externalization model depending different phases of the facility life cycle.
As a member of the clinical facility Leadership Team, he/ she will partner with all functions to achieve the Facility Business Objectives.
Demonstrated leadership skills, including leading cross-functional teams
Ability to resolve technical manufacturing issues, interface with internal and external engineering/technical experts, and manage multiple priorities in a manufacturing environment setting
Excellent communication and presentation skills, both oral and written, with a demonstrated ability to present key quality/department/business indicators to senior management
As the plant resources will be lean and agile, incumbent is expected to perform execution of the vision apart from strategizing.
Ability to drive change and motivate others toward a common vision
Excellent facilitation, problem-solving, and analytical skills
Must be confident, resourceful, creative, self-reliant, and self-motivated
Understanding of global cGMP regulations and quality management systems for pharmaceutical or biotechnology operations, including participation in regulatory inspections
Excellent interpersonal, influencing, and negotiating skills
Strong understanding of project management, organizational, planning, and analytical skills
Preferably to have working knowledge of manufacturing techniques, including Lean and Six Sigma
Responsible for the outgoing quality, safety, process, and compliance with all applicable specifications, Standard Operating Procedures, FDA regulations (GMP’s) and New Drug Applications.
Ensures budgets, schedules, capacity, and performance requirements are met.
Ensure reliable operations through design of equipment, facilities, and processes.
Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.
Propose and devise strategies for improvements through coordination with cross functional teams and R&D/CMC organization.
Responsible for resolving complex problems where analysis of situations or data requires an in-depth evaluation of multiple factors.
Must execute judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Regularly interacts with senior management on matters concerning several functional areas, division, and/or collaborators.
Establish and maintain an environment that stresses and encourages teamwork.
Responsible for defining near-term and long-term strategic plans for the GMP organization. Implements required actions, aligned staffing plan, and organizational development to deliver committed results
Regularly interacts with leaders from Quality, Engineering, Supply Chain, Technical Services, and other functions to resolve issues, drive improvement activities, and prioritize initiatives and resources
Develops self, direct reports, and high potential employees.
May perform other duties as assigned
Has the ability and willingness to learn from experience, and subsequently apply that learning to perform successfully under new or first-time conditions
Education, Behavioural Competencies And Skills
15+ years of related experience with 10+ years of experience in a Biopharmaceutical/Pharmaceutical in a management/manufacturing leadership role
Requires a bachelor’s degree, preferably in Science, Engineering, or other related technical fields. Master’s Degree preferred
Must have previous relevant experience leading manufacturing operations with a proven track record of success in leading complex organizations
Experience in Operational Excellence, Lean Manufacturing, and DMAIC, with a proven record of driving operational improvements
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
Must be able to work in controlled environments for 3-5 hours requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body