Position Summary:
The purpose of this job is to: manage, plan, organize and direct the activities related to Quality Control to ensure timely completion of the functional tasks; manage the development and implementation of related programs to maximize efficiencies and effectiveness of the function and budgetary resources necessary to support the company goal while complying with regulatory requirements; operate in accordance with company policies and procedures, FDA Regulations, ISO Standards. Provide oversight of the commercial product stability program. Ensure all laboratory equipment is calibrated and maintained to meet all regulatory requirements. Ensure all analytical methods are properly validated/verified prior to use. Review and approve all laboratory OOS investigations for accuracy, completeness, and appropriate root cause analysis. Take immediate action to resolve issues and escalate to upper management as necessary.
Responsibilities
- Understands and communicates corporate vision, strategies, and goals to department personnel.
- Lead, develop and mentor team of Quality Control professionals providing support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement to Quality.
- Responsible for the recruitment, training, and retention of QC staff, fostering a positive work environment that emphasizes collaboration and professional growth.
- Oversight and approval of Out of Specification Reports and Investigations, conducting problem solving and root cause analysis activities.
- Oversight and responsibility to ensure site maintains adherence to Quality KPIs (Key Performance Indicators) and takes timely action to address adverse trends and deviations. Continuously monitors and assesses opportunities for improvement.
- Work collaboratively with Planning, Supply Chain, R&D Labs, QA, Manufacturing, Validation, and Operations to drive continuous improvement.
- Interfaces directly with customers and suppliers as needed.
- Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.
Conduct regular performance reviews, set clear performance expectations, and develop individual and team performance improvement plans.
- Coordinate and Oversee multiple laboratory functions ( Microbiology, Analytical and Quality Control Labs) to ensure cross-functional alignment and efficient workflow.
- Performs other duties and assignments as required.
Required Skills/Abilities
- Demonstrated leadership experience with the ability to effectively manage, motivate, and develop a team.
- Excellent written, verbal and interpersonal communication skills
- Prioritize multiple responsibilities and manage deadlines accordingly.
- Acute attention to detail and high level of organization and accuracy
- Proactive nature – must want to learn and develop in the role
- Strengths in developing and maintaining customer relationships.
- Able to work autonomously but must be able to work across teams.
- Works in both office/lab and manufacturing environments.
- Must be able to handle sensitive related and proprietary information in a confidential manner.
- Experience in developing laboratory SOPs and revisions according to regulatory guidelines
- Strong knowledge of GMP, ISO, Data Integrity and safety guidelines
- Ability to analyze and solve problems.
- Proficient with Microsoft Office
RequiredEducation and Experience
- A minimum of a bachelor’s degree in chemistry.
- A minimum of 5-10 years of management experience in a Quality Control laboratory environment
- A minimum of 5 years of analytical chemistry experience in the pharmaceutical industry.
Preferred Education and Experience
- PhD or master’s degree in chemistry
- A minimum of 7 years of analytical chemistry experience in the pharmaceutical industry.
