- Directs and prioritizes the Quality Control laboratory to provide for the timely and accurate testing of raw materials, in-process and finished goods, and stability programs and production processes while ensuring compliance with protocols, cGMP and safety regulations.
- Develops budgets to maintain departmental functions at lowest possible cost consistent with quality and operates within the limits of the budget approved.
- Ensures all vendors have been qualified and adhere to vendor qualification standards with the aim of optimal utilization of testing procedures.
- Ensures safety of QC staff through training, policies and cGMP adherence, and support of the JHSC meetings and inspections.
- Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results.
- Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
- Monitors QC systems and advises management team on system performance; publishes metrics regarding performance against set goals and makes recommendations.
- Leads in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence;
- Acts as a subject matter expert for laboratory investigations, deviations, and CAPA, ensuring timely closer of all quality events.
- Acts as the primary point of contact for laboratory investigations information with internal and external auditors and regulatory inspectors.
- Supports and implements continuous quality improvement and lean laboratory initiatives in accordance with GLP.
- Develops, reviews and revises laboratory Standard Operating Procedures as required.
- Ensures the department is adequately equipped with up to date instrumentation and equipment that is properly calibrated and serviced. Maintains knowledge of state-of-the-art technologies and instrumentation and implements or acquires these as needed.
- 5 years’ relevant experience in a regulated Pharmaceutical industry including Quality Control, with 3 years in a leadership role
- BSc degree in science.
- Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems.
- Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
- MS degree or MBA as asset
Competencies required for the role:
- COGNITIVE FLEXIBILITY – Is the ability to switch from one behavior to another depending on requirements, and reflect on several options to solve problems quickly.
- COMPLEXITY/STRESS MANAGEMENT /TIME MANAGEMENT-The ability to keep functioning effectively when under pressure and maintain self-control in the face of hostility or provocation. Cuts through complexity to focus on core issues; ability to manage time smartly; manages resources soundly.
- CUSTOMER ORIENTATION – The ability to demonstrate concern for satisfying one’s external or internal customers. Identifies and prioritizes customer needs and recognizes constraints. Seeks to find out more about customers and provide better service. Is professional, reliable and delivers on promises. Brings a competitive focus to customer.
- DELEGATION – is the assignment of authority to another person to carry out specific activities. It is the process of distributing and entrusting work to another person. It is not only giving the responsibility to do the work but the authority to do the work. It is one of the core concepts of management leadership. The ability to convey confidence in employee’s ability to be successful.
- INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.