Manager, Quality Control Laboratory

CareAbout•Harleysville, PA

9d•$126,702 - $169,000

About The Position

The Manager, Quality Control (QC) Laboratory oversees the laboratory activities and ensures the highest standards of accuracy, efficiency, and compliance. The incumbent plays a critical role in team leadership and operational management and directly influences the laboratory’s growth and alignment with pharmaceutical industry standards and regulatory requirements. QC Laboratory activities cover but are not limited to the following main tasks: Finished Product Release Testing In Process Control (IPC) Testing Finished Product Stability Testing Stability Program Raw Materials Testing (Internal and External Testing) Method Development and Validation (Phase II/III and Commercial Products) Environmental Monitoring (Internal and External Testing) Cleaning Verification Testing Cleaning Method Validation

Requirements

Bachelor’s degree in engineering, Chemistry, Pharmaceutical Sciences, or related field (Master’s degree preferred).
10+ years of progressive experience in pharmaceutical QC Laboratory within a GMP environment.
5+ years of management experience, preferably within a CDMO or Pharmaceutical Industry QC Laboratory setting.
Working knowledge of EPA, DEA, OSHA regulations as it relates to the QC Laboratory controls.
Pharmaceutical Industry QC Laboratory advance training and certification
MS Word, Excel, Outlook and Power Point
Ability to interpret Pharmaceutical Industry QC Laboratory documents and industry specific manuals.
Ability to write advanced reports and correspondence.
Independent thinker, proactive mindset, solution oriented, can-do-attitude, and results oriented to achieve successes while ensuring people-based leadership behavior.
Experience with multiple dosage forms (e.g., solid oral, sterile, biologics, or specialized manufacturing).
Prior experience supporting regulatory inspections and client audits.
Strong business acumen with experience in budget management.
Excellent verbal and written communication skills.
Well-developed interpersonal skills are required.
Strong knowledge of cGMP regulations, FDA/EMA requirements, and pharmaceutical quality systems.
Working knowledge of OSHA, EPA, and DEA standards.
Demonstrated experience leading commercial and/or clinical QC Laboratory setting.
Proven ability to manage complex operations, client expectations, and cross-functional teams.
Personal/professional integrity and proven discretion in handling confidential information.
Ability to develop strong trusting relationships to gain support and achieve results.
Capable of managing multiple priorities.
Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
Capable of lifting up to 50 weights

Nice To Haves

Master’s degree preferred

Responsibilities

Provide strategic and day-to-day leadership for GMP Quality Control Laboratory operations, including commercial, and clinical phase II/III supply.
Manages the QC Laboratory team providing growth opportunities for staff and accomplishing results by communicating job expectations, planning, monitoring, and appraising job performance.
Develop, coordinate, and enforce department systems, policies, procedures, and productivity standards, to ensure optimal performance as well as robust operational strategies that will enhance service delivery and client satisfaction.
Communicates QC Laboratory Key Performance Indicators to Site Leadership Team and General Manager.
Maintains compliance with all relevant GMP regulatory requirements and laboratory certifications.
Formulate and manage laboratory budget, ensuring cost-effectiveness and resource optimization targeting resources allocated for the QC Laboratory profit center.
Identify opportunities to improve efficiency, reduce costs, and increase throughput without compromising quality.
Maintain continuous engagement with key clients, ensuring alignment with their evolving needs.
Enforce rigorous health and safety standards to protect staff and ensure environmental compliance.
Review and approve analytical method validation protocols and reports, test procedures, stability protocols, and development reports.
Participate in review and approval of GMP change controls.
Review and advise on analytical investigations of OOS and OOT results in a cGMP environment. Propose, enact, and enforce corrective actions.
Schedules and executes on time the QC Laboratory work plan in compliance with Quality requirements.
Oversees capacity planning, resource allocation, and laboratory readiness to support current and future client demand.
Ensures full compliance with FDA, EPA, DEA, OSHA and other regulatory requirements.
Partners with Quality to support audits, inspections, and regulatory submissions covering the QC Laboratory activities.
Owns QC laboratory related deviations, OOS investigations, CAPAs, and change controls.
Promotes a strong culture of quality, data integrity, and regulatory compliance within the laboratory.
Acts as a key QC Laboratory representative for client engagements, technical discussions, and governance meetings.
Ensures QC laboratory execution meets contractual obligations, timelines, and quality expectations.
Support technology transfer activities and scale-up from development to commercial manufacturing.
Build, lead, and develop high-performing QC laboratory teams, including supervisors, and frontline staff.
Establish clear goals, accountability, and succession planning for his/her team.
Foster a culture of safety, collaboration, accountability, and continuous improvement.
Partner with Quality, Procurement, Program Management, Pharmaceutical Development and EHS to ensure seamless laboratory operations.
Support capital projects, equipment qualification, and laboratory expansions as required.
Support business development activities through review of client proposals as needed.
Ensure site OPEX/CAPEX are actively managed, tracked and executed in a timely manner.
Ensure SAT/IQ/OQ/PQ/PM/Calibration of laboratory equipment.