Our Biotech client specializing in Cell and Gene Therapy is seeking a Quality Control Manager (2nd shift) who will play a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Reporting to the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: 

• Devising sound hiring strategies based on business needs
  
• Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of company and/or client products/materials
• Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance
• Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies
• Assuring alignment and efficient continuity in laboratory practices between sites
• Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records
• Ensuring completion of all client QC requirements related to GMP cellular products and/or materials
• Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable
• Prioritizing, scheduling, and managing multiple projects and resources simultaneously
• Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings
• Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function
• Delegating maintenance, tracking, and trending aspects of the deviation reporting system
• Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing
• Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable
• Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation
• Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities
• Participating in and tracking group budget setting and cost containment drives
• Communicating and maintaining trust relationships with senior management, business partners, and clients
• Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times
• Completing projects and special tasks as assigned by the Global Quality Head
• Off-schedule shifts during weekends and holidays based on business requirements a possibility
• On-call presence preferred while physical personal presence is not possible
• Candidate will oversee QC Scientist and QC Associate I, Hiring, developing, training, and evaluating QC personnel II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.

 REQUIREMENTS

• BA/BS/MS in a science or relevant field required
• Master’s in Business Administration or relevant field will be preferred
• Prior cGMP experience required
• Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must
• 7-10 years’ experience in the pharmaceutical, biologics or related industry
• Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position preferred
• Sound understanding of current Good Manufacturing Practices (cGMPs)
• Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation
• Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred
• Proven experience in a supervisory or managerial position
• Demonstrable experience in developing strategic plans based on business needs
• Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries
• Thorough knowledge of market changes and forces that influence the company
• Proficient with computer software such as: Microsoft Office, Visio
• Strong written, oral, and presentational skills
• Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers
• Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
• Excellent organizational and leadership skills
• Excellent communication, interpersonal, and presentation skills
• Outstanding analytical and problem-solving abilities
• Strong business acumen
• Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner
• Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities
• While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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