Head Of Quality Control & Quality Assurance

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods

The Quality Control (QC) Manager is responsible for leading and managing Quality Control laboratory operations to ensure the timely testing, release, and compliance of raw materials, in-process materials, bulk, stability, and finished products. This role ensures adherence to current Good Manufacturing Practices (cGMP), FDA regulations, and company quality standards while providing strong leadership, technical expertise, and continuous improvement within the QC function.

Monday- Friday 8am-5pm

Bachelor’s or Master’s Degree in Chemistry, Biology, or a related scientific discipline

Minimum of 7 years of experience in a Quality Control laboratory environment within a regulated industry (pharmaceutical, biotech, or related)

Strong working knowledge of cGMPs, FDA regulations, and FDA guidance documents

Demonstrated leadership and people management experience

Proven ability to plan, organize, and manage multiple priorities and projects simultaneously

Strong attention to detail with consistent focus on data integrity and compliance

Computer proficiency, including experience with laboratory systems and standard office software

Directly supervise and provide leadership to QC laboratory technical and support staff

Manage the development, implementation, and continuous improvement of QC goals, objectives, procedures, and systems in alignment with company policies and cGMP requirements

Establish, review, and maintain analytical procedures, methods, and testing guidelines

Establish and maintain testing schedule to assure adherence to Quality On Time Release (OTR), including Raw Materials, In-Process, Finished Product and Stability

Recruit, train, coach, and develop QC staff; assign work, monitor performance, and conduct performance evaluations

Perform or oversee analytical testing, data review, and approval activities as needed

Oversee raw material testing, in-process testing, bulk testing, stability testing, and finished product testing

Ensure the development, review, approval, and maintenance of Certificates of Analysis for bulk and finished products

Oversee the laboratory equipment qualification, calibration, and maintenance programs

Develop, review, and maintain Quality Control Standard Operating Procedures (SOPs)

Support internal and external audits, inspections, and regulatory agency interactions as required

Partner cross-functionally with Quality Assurance, Manufacturing, R&D, and other departments to support product quality and continuous improvement initiatives

Perform additional duties as assigned by the Head of Quality

Ensure QC Laboratory compliance with 21 CFR 210 & 211 and Part 11

Lead as an QC SME for Internal, Client and Regulatory Audits as needed

Adhere to all safety policies, including the use of personal protective equipment when required

Light physical activity performing non-strenuous administrative and laboratory duties

Sitting for greater than 75% of the workday; Manual dexterity sufficient for handling laboratory equipment, samples, and computer work

Use of hands and fingers for typing and laboratory tasks up to 75% of the time

Medical and Dental Benefits

• Group Life Insurance
• Flex Spending Accounts
• Paid Time Off and Paid Holidays
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

#