Quality Control Manager

Job Description

Quality Control Manager The Quality Control (QC) Manager plays 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. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to:

Leading, hiring, developing, training, and evaluating QC personnel

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 HCATS 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, 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

7 – 10 years’ experience in the pharmaceutical, biologics or related industry

Prior cGMP experience required

Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must

Experience in Flow Cytometry is a must

5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff

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: 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 responsibilitiesWhile 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. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility 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.