QA Validation Manager

LNK International, Inc.•Town of Smithtown, NY

6d•$115 - $128•Onsite

About The Position

LNK International, a leading OTC pharmaceutical manufacturer located in Hauppauge, Long Island, New York, is seeking an experienced QA Validation Manager to join its Quality department. The role reports to the Director, Quality Assurance and supports compliant management of commercial OTC products. The company is seeking a long-term team member to become part of its technical team. The manager leads QA validation work for commercial manufacturing of solid and liquid oral-dose OTC products. The role establishes and maintains the site Master Validation Plan, reviews and approves equipment and computer-system validation documentation, and provides regulatory compliance guidance to project teams, IT personnel, business users, and trainers. It also oversees computer-system validation and lifecycle activities, investigates validation-related quality issues, and serves as a subject matter expert during regulatory, third-party, and client audits.

Requirements

Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or a related scientific discipline.
At least five years of validation experience in an FDA-regulated pharmaceutical or OTC drug manufacturing environment.
At least two 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 supporting commercial manufacturing of solid and liquid oral-dose OTC products.
Establish and maintain the site Master Validation Plan in alignment with business goals and FDA/OTC regulatory expectations.
Advise project teams on compliance and technical strategy for validation activities to meet company policies and government regulations.
Review and approve validation specifications, protocols, and reports, focusing on cGMP impact, equipment qualifications (IQ/OQ/PQ), 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, 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 on computer-system validation compliance issues.
Oversee computer-validation activities and generate SOPs and other documentation required to maintain compliance.
Assist with modifying and configuring software applications based on user feedback and industry standards.
Review training materials such as user guides, work instructions, and quick reference guides; work with trainers and subject matter experts to ensure training is effective and meets participant needs.
Provide QA compliance input on software usability to support effective use of functionality.
Lead root-cause investigations for validation-related deviations, OOS data, and CAPAs related to 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.