Quality Assurance Supervisor

1 week ago

Saddle River, New Jersey, United States Lynkx Staffing LLC Full time
Job Overview

The Quality Control Manager is essential in guaranteeing that the Quality Control (QC) department effectively supports both clinical and commercial production processes. This role involves overseeing analytical testing for process checkpoints, stability assessments, and release assays to ensure that all products meet established quality standards.

The primary objective is to ensure that the Quality Control team and the organization consistently progress towards achieving both short-term and long-term goals while adhering to strategic guidelines. Reporting directly to the VP of Global Quality, the QC Manager's responsibilities include but are not limited to:

  • Leading, recruiting, developing, training, and assessing QC staff.
  • Creating effective hiring strategies aligned with business requirements.
  • Supervising QC personnel to ensure safe and efficient verification, approval, and release of products.
  • Delegating tasks and guiding laboratory staff to maximize performance.
  • Ensuring compliance with applicable cGMP and GTP regulations, as well as company and client methodologies.
  • Facilitating alignment and continuity in laboratory practices across different sites.
  • Acting as an approver in investigations and ensuring timely resolution of deviation reports, change controls, CAPAs, and relevant batch records.
  • Overseeing the completion of all client QC requirements related to GMP cellular products.
  • Managing QC involvement in material dispositions through deviation reporting systems and client-based systems.
  • Prioritizing, scheduling, and managing multiple projects and resources concurrently.
  • Monitoring the effectiveness of quality systems and change control activities in response to internal and client audit findings.
  • Evaluating customer complaints and deviations, coordinating corrective and preventive actions related to Quality Control.
  • Maintaining and tracking the deviation reporting system.
  • Developing and tracking Key Performance Indicators (KPIs) for laboratory testing.
  • Collaborating with vendors, suppliers, and in-house production teams to implement effective corrective actions for recurring discrepancies.
  • Engaging with management at all levels to ensure alignment on significant deviation resolutions and corrective actions.
  • Overseeing the development and implementation of Standard Operating Procedures related to Quality Control activities.
  • Participating in budget setting and cost containment initiatives.
  • Maintaining strong relationships with senior management, business partners, and clients.
  • Ensuring adherence to company policies and legal guidelines throughout the organization.
  • Completing special projects and tasks as assigned by the Global Quality Head.
  • Being available for off-schedule shifts during weekends and holidays as required.
  • Providing on-call support when physical presence is not feasible.
  • Overseeing QC Scientists and QC Associates, delegating responsibilities to meet business needs while supporting manufacturing processes.
Qualifications
  • 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 in a leadership role is necessary, demonstrating the ability to lead, coach, and motivate staff effectively.
  • Strong understanding of current Good Manufacturing Practices (cGMPs).
  • Familiarity with routine QC laboratory procedures such as flow cytometry, CBC analysis, and endotoxin testing.
  • Experience reviewing Standard Operating Procedures, work instructions, and protocols is preferred.
  • Proven supervisory or managerial experience is required.
  • 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 affecting the company.
  • Proficiency in Microsoft Office and Visio.
  • Excellent written, oral, and presentation skills.
  • Strong knowledge of QC analytical testing methodologies and quality systems.
  • Outstanding organizational and leadership capabilities.
  • Exceptional communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Business acumen and strategic thinking abilities.
  • Detail-oriented with the ability to multitask and adapt to evolving responsibilities.

While performing the duties of this position, employees may be exposed to infectious diseases and are expected to utilize universal precautions. Other potential exposures include gases and corrosive chemicals. The work environment may be moderately noisy, and the ability to work collaboratively with clients and team members is essential.

This job description is not intended to be a comprehensive listing of all activities, duties, or responsibilities required of the employee. Responsibilities may change at any time with or without notice.

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