Position Summary
The incumbent will be responsible for overall management of the Quality Control (QC) Laboratory services and their related support teams. With extensive knowledge of compliance requirements relating to the QC function together with excellent verbal, written, and interpersonal communication skills the incumbent will need to be action-orientated, agile with respect to change management and a strong leader for the quality culture of the Laboratory and the site to achieve the site Quality Control operational objectives. Key accountabilities include:
- Lead, coach and develop a team of QC Managers, supervisors and their related laboratory teams ensuring that analytical (physical, chemical and microbiological) testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures (SOPs) and are performed in a safe and reliable manner to support manufacturing operations at the site and across all shifts.
- Ensure that the quality systems in the Laboratory are continually audited with new requirements implemented and all QC related operations comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards (PQS).
- Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.
Responsibilities:
- Responsible for developing and managing integrated Quality Systems and providing technical support and advice on Quality Control matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
- Responsibility of setting up and implementing QC Laboratory quality systems and strategies for developing and implementing monitoring systems to collect, collate and present information on Quality Control Laboratory for performance management and bench marking. This includes review and approval of Standard Operating Procedures (SOPs) and periodic review processes.
- Responsibility for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
- Plan and track Quality Control objectives, timelines, priorities, and resources.
- Develop, write and present business cases for equipment, staff resources and service developments.
- Manage and ensure the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements so as to provide accurate test results for correct GMP usage decisions.
- Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
- Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed).
- Ensure that the laboratory equipment are qualified to meet regulatory standards, well maintained and in good working order.
- Work closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
- Manage and provide oversight of the strategy and execution of Analytical Method Transfer Exercise (AMTE) from other Pfizer sites and Centre functions for new products introduced to the site. This involves the development / validation / verfication of new /existing analytical methods for testing starting materials, process intermediates, APIs and plant cleaning samples.
- Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.
- Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and Continuous Improvement Projects (CIP). Using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.
- Ensure the product stability programs are managed and testing data (including stability data) is reported for Annual Product Review Reports (APRRs) and regulatory filing in a timely manner.
- Ensure laboratory automation is functional at all times and supports laboratory efficiency.
- Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.
- Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.
- Uphold Pfizer's code of conduct and values.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
- Collaborate with cross-functional teams to drive flawless execution.
- Fulfil requirements of a first line leader (FLL) as described in site procedure that includes (but is not limited to) the below:
- Engage and inspire team on performance expectations and coach the team to meet expectations using Coaching Skills principles
- Effectively monitor the actions of team members. Ensure presence in the GMP work area to observe work activity and practices.
- Be available for direct report(s) for real time escalation of any concerns or support needs
- Be accountable for Good Data Management and Data Integrity understanding and performance of the team
- Be a role model to support a positive compliance culture
- Be vigilant for potential actions or behaviour that could result in breaches of GMP compliance or Data Integrity principles
Job Related Requirements:
- Effective problem solving skills.
- Demonstrated leadership, management and customer service skills.
- Excellent verbal, written and interpersonal communication and presentation skills.
- Demonstrated ability to interact effectively with senior management, auditors and regulators.
- Strong knowledge of analytical chemistry, analytical method validation, instrumentation, laboratory automation and production processes.
- Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
- Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment, experience in Empower software.
- Knowledge of six sigma, lean labs and standard work practices.
- Possess a can-do / pride to succeed attitude and be a positive influencer/role model.
- Embrace the use of digital technology to scale and speed up every form of interaction and action.
Education
Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.
Experience
- Minimum 8-10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
- Minimum 5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams.
- Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
- Experience in an API manufacturing plant is preferred.
- Effectively communicate through written and oral means, demonstrated ability to interact effectively with senior management, auditors and regulators.
The incumbent will have the following core competencies:
- Project Management skills
- Team Leadership skills
- Communication skills
- Analytical skills
- OPEX skills
