QC Laboratory Leader – GMP & Compliance

Altasciences; Harleysville (PA); On-site; USD 127,000 - 169,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Job summary

Altasciences in Harleysville, PA seeks a Manager, Quality Control Laboratory to lead GMP QC operations for commercial and clinical phase products. You will drive strategy, KPIs, budgeting, audits, and continuous improvement while developing a high-performing team.

Responsibilities include method validation reviews, change control, CAPAs, and ensuring FDA/EPA/DEA compliance. This role partners with Quality, Program Management, and EHS to deliver quality on time.

Qualifications

• 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

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.

Skills

GMP compliance

Budget management

Leadership

Quality systems

Regulatory inspections

cGMP knowledge

Cross-functional leadership

Documentation/report writing

Multi-dosage forms

Audit readiness

Education

Bachelor’s degree in engineering/chemistry/pharm sciences

Master’s degree preferred

Tools

MS Word

Excel

Outlook

PowerPoint

Job description

Altasciences in Harleysville, PA seeks a Manager, Quality Control Laboratory to lead GMP QC operations for commercial and clinical phase products. You will drive strategy, KPIs, budgeting, audits, and continuous improvement while developing a high-performing team.

Responsibilities include method validation reviews, change control, CAPAs, and ensuring FDA/EPA/DEA compliance. This role partners with Quality, Program Management, and EHS to deliver quality on time.