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Quality Assurance Operations Leader
2 months ago
Quality Control Manager
The Quality Control (QC) Manager is essential in guaranteeing that the QC department effectively supports both clinical and commercial production operations. This role involves overseeing analytical testing for process checkpoints, stability assessments, and release assays to ensure that quality standards are consistently met for all products manufactured at the facility.
The primary objective is to ensure that the Quality Control team and the organization continually progress towards achieving both short-term and long-term goals while adhering to strategic guidelines.
Key Responsibilities- Lead, recruit, develop, train, and assess QC personnel.
- Formulate effective hiring strategies aligned with business requirements.
- Supervise QC staff to ensure safe and efficient verification, approval, and release of products.
- Delegate tasks and oversee laboratory personnel while providing guidance to enhance performance.
- Promote compliance with applicable cGMP and GTP regulations, ensuring adherence to company and client methodologies.
- Ensure alignment and seamless continuity in laboratory practices across various sites.
- Act as an approver in investigations, ensuring timely resolution of deviation reports, change controls, CAPAs, and relevant batch records.
- Guarantee completion of all client QC requirements concerning GMP cellular products and materials.
- Oversee QC's role in material dispositions through deviation reporting systems and client-based systems, as necessary.
- Manage multiple projects and resources concurrently, prioritizing and scheduling effectively.
- Monitor the effectiveness of quality systems and change control activities, ensuring completion in response to internal and client audit findings.
- Evaluate and investigate customer complaints and deviations, coordinating corrective and preventive actions related to the Quality Control function.
- Oversee maintenance, tracking, and trending of the deviation reporting system.
- Develop and maintain Key Performance Indicators (KPIs) for laboratory testing.
- Collaborate with vendors, suppliers, and in-house production teams to implement effective corrective and preventive actions for recurring discrepancies.
- Engage with management at all levels to ensure alignment on significant deviation resolutions and corrective action implementations.
- Delegate the development, revision, and implementation of Standard Operating Procedures related to Quality Control activities.
- Participate in group budget setting and cost containment initiatives.
- Maintain trust relationships with senior management, business partners, and clients through effective communication.
- Ensure that company policies and legal guidelines are communicated and adhered to throughout the organization.
- Complete projects and special tasks as assigned by the Global Quality Head.
- Be available for off-schedule shifts during weekends and holidays based on business needs.
- Provide on-call support when physical presence is not feasible.
- Supervise QC Scientists and QC Associates, delegating responsibilities to meet business needs while supporting manufacturing processes.
- BA/BS/MS in a scientific or relevant field is required.
- A Master's in Business Administration or a related field is preferred.
- 7 to 10 years of experience in the pharmaceutical, biologics, or related industry.
- Prior cGMP experience is essential.
- Experience in QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology within a cGMP/GTP environment is mandatory.
- Experience in Flow Cytometry is required.
- A minimum of 5 years of experience leading a team is necessary, demonstrating the ability to lead, coach, and motivate employees effectively.
- Strong understanding of current Good Manufacturing Practices (cGMPs).
- Familiarity with routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, and production processes.
- Experience in reviewing Standard Operating Procedures, work instructions, protocols, and method validations is preferred.
- Proven experience in a supervisory or managerial capacity.
- Demonstrated ability to develop strategic plans based on business needs.
- Strong understanding of Quality Control in the pharmaceutical/biotechnology/biologics sectors.
- Thorough knowledge of market dynamics and factors influencing the company.
- Proficient in Microsoft Office and Visio.
- Excellent written, oral, and presentation skills.
- Strong knowledge of QC analytical testing methodologies, method validation, and method transfers.
- Solid understanding of quality systems and the ability to interpret quality standards for implementation and review.
- Exceptional organizational and leadership capabilities.
- Outstanding communication, interpersonal, and presentation skills.
- Strong analytical and problem-solving skills.
- Robust business acumen.
- Ability to think strategically and tactically while advising personnel effectively.
- Detail-oriented with the capacity to multitask, work collaboratively, and adapt to the evolving responsibilities of the company.
While performing the duties of this position, employees may occasionally encounter infectious diseases transmitted through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other potential exposures may include gases (nitrogen) or corrosive chemicals (Clorox, potassium hydroxide), as well as liquid nitrogen. The work environment may be moderately noisy. Candidates must be able to work effectively in a team-oriented environment and with clients.
Please note that this job description is not intended to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this position. Duties, responsibilities, and activities may change at any time with or without notice.
