QC Laboratory Director: GMP Leader & Strategy

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

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k) with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Job summary

CareAbout is seeking a Manager of Quality Control Laboratory to lead GMP QC operations, ensuring accuracy, compliance, and client satisfaction. You will manage staff, develop SOPs, and coordinate budgets while supporting audits and regulatory submissions.

The role requires extensive QC experience, strong leadership, and the ability to drive continuous improvement in a fast-paced pharmaceutical environment. This position is based in Harleysville, PA and involves collaboration across QA,

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 in a CDMO or Pharmaceutical QC Laboratory setting.
• Working knowledge of EPA, DEA, OSHA regulations as it relates to 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 manuals.
• Strong leadership mindset with results-oriented, people-based approach.

Responsibilities

• Provide strategic and day-to-day leadership for GMP QC Laboratory operations, including commercial and clinical phase II/III supply.
• Manages the QC Laboratory team, developing staff and achieving results via clear expectations and performance reviews.
• Develop, coordinate, and enforce department policies to improve performance and service delivery.
• Communicate QC Laboratory KPIs to Site Leadership Team and GM.
• Maintain compliance with FDA, EPA, DEA, OSHA and other regulatory requirements.
• Manage laboratory budget, ensuring cost-effectiveness and resource optimization.
• Identify opportunities to improve efficiency, reduce costs, and increase throughput.
• Support audits, inspections, and regulatory submissions for QC activities.
• Lead capital projects and equipment qualification; support tech transfer.

Skills

GMP knowledge

Regulatory knowledge

Budget management

Leadership

Communication

Cross-functional teams

Education

Bachelor’s degree in engineering, Chemistry, Pharmaceutical Sciences, or related field

Tools

MS Word

Excel

Outlook

PowerPoint

Job description

CareAbout is seeking a Manager of Quality Control Laboratory to lead GMP QC operations, ensuring accuracy, compliance, and client satisfaction. You will manage staff, develop SOPs, and coordinate budgets while supporting audits and regulatory submissions.

The role requires extensive QC experience, strong leadership, and the ability to drive continuous improvement in a fast-paced pharmaceutical environment. This position is based in Harleysville, PA and involves collaboration across QA,