QA Validation Manager

LNK International•Hauppauge, NY

About The Position

LNK International, a leading OTC pharmaceutical manufacturer in Hauppauge, Long Island, New York, is seeking an experienced Quality Assurance Validation Manager to join its Quality department. The department is responsible for compliant management of product complaints associated with commercial OTC products. The position reports to the Director, Quality Assurance and is intended for a long-term team member who will contribute to a strong technical team. The manager leads Quality Assurance input and oversight for validation projects supporting commercial manufacturing of solid and liquid oral-dose OTC products. Responsibilities cover equipment qualification and validation, computer systems validation, cGMP and regulatory compliance, training support, change control, and investigation of validation-related issues. The role also serves as a subject matter expert during FDA, third-party, and client audits. LNK offers competitive compensation and a full benefits package, including health and dental insurance and a 401(k). The posting notes that any base compensation offered may be determined by several factors permitted by law. LNK is an equal opportunity employer and prohibits discrimination on protected grounds.

Requirements

Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or a related scientific discipline.
At least 5 years of validation experience in an FDA-regulated pharmaceutical or OTC drug manufacturing environment.
At least 2 years of supervisory or managerial experience leading a technical validation team.
Experience in Quality Assurance batch record auditing, compliance, or validation.
Experience in software configuration, installation, and/or system integration.

Responsibilities

Lead QA input to validation projects for commercial manufacturing of solid and liquid oral-dose OTC products.
Establish and maintain the site Master Validation Plan (MVP), aligning it with business goals and FDA/OTC regulatory expectations.
Advise project teams on compliance and technical strategy for validation activities and help ensure adherence to company policies and government regulations.
Review and approve validation specifications, protocols, and reports, focusing on cGMP impact, IQ/OQ/PQ equipment qualifications, and the validation lifecycle.
Review commissioning and validation documentation for manufacturing equipment, including fluid bed dryers, tablet presses, encapsulation machines, mixing tanks, and high-speed filling and packaging lines.
Participate in validation project teams and provide regulatory-compliance guidance and direction.
Provide QA oversight and input for computer validation projects supporting commercial manufacturing in a cGMP environment.
Oversee company eSystems validation plans, protocols, traceability matrices, acceptance criteria, independent testing, and preparation of final summary reports.
Provide QA compliance guidance, training, and support to IT personnel and business users conducting validation work.
Oversee IT and business-team testing efforts, including requirements, resource planning, test coverage, and test strategies.
Review proposed changes to validated computer systems and determine validation requirements needed to maintain their validated state.
Approve validated computer system change requests and provide QA oversight of SDLC documentation and 21 CFR Part 11 compliance.
Assist IT with the design, review, and approval of test plans, test scripts, and test procedures.
Review and approve computer validation change-control activities in accordance with site procedures.
Interact with clients and regulatory investigators regarding computer system validation compliance issues.
Oversee computer validation activities and generate SOPs and other documentation as needed to maintain compliance.
Assist with modifying and configuring software applications based on user feedback and industry standards.
Review user guides, work instructions, quick reference guides, and other training materials; work with trainers and subject matter experts to ensure training is effective and meets participant needs.
Provide QA compliance input on software usability and effective use of functionality.
Lead root cause investigations into validation-related deviations, OOS data, and CAPAs associated with solid or liquid batch failures or equipment malfunctions.
Serve as the subject matter expert during FDA, third-party, and client audits, defending validation designs, protocols, cleaning validation matrices, and data records.