QA Validation & Compliance Lead

The Quality Assurance Validation and Compliance Lead is a hands-on, cross-functional leader with a passion for driving quality in both laboratory and manufacturing environments. This position is accountable for quality leadership and collaborates with internal and external key stakeholders to drive results for customer projects. The position requires strong leadership behaviors and core competencies and non-negotiables, as well as expertise in the functional competencies associated with the business unit assigned.

Primary Responsibilities:
• Provide quality and compliance oversight for the qualification and validation, of manufacturing, facility, computer systems and software applications, and laboratory systems to ensure the life of equipment and computerized system remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures.
• Review and approve validation documentation including but not limited to: Validation Master Plans, User Requirements, Functional Requirements, Data Integrity Assessment, FATs, SATs, IQOQPQ, Trace Matrix, Validation Summary Reports, and Change Controls.
• Review validation documentation to ensure data accuracy, consistency, and reliability within the organizations database systems and processes.
• Provide quality and compliance oversight for scheduled and periodic maintenance activities for all GMP systems within the manufacturing and testing facility. This includes review and approval of documentation including support for assessing impact on planned and unplanned maintenance work orders for equipment and instruments.
• Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain.
• Manage multiple and complex projects, provide status reports, and coordinate with other departments and/or outside contractors/vendors to complete validation tasks.
• Define decision criteria and determine the most appropriate course of action.
• Provide concise and clear documentation through strong written communication skills.
• Partner with a team setting to support continuous improvement initiatives. Support technical and quality investigations to resolve issues.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Maintain minimal direction to complete tasks, understand how to obtain resources and information from established internal contacts, and consult with manager for decisions outside established processes.
• Perform other related duties as assigned.

Education, Experience, & Qualification:
• Bachelor’s degree in scientific or engineering discipline required.
• 7-15 years of related pharmaceutical experience required, including relevant experience in manufacturing in a GMP environment or a combination of education and experience.
• Experience in equipment and computer system validation within the pharmaceutical, biotechnology, medical device, or related industry.
• Knowledge of regulatory requirements (e.g., FDA, EMA, GxP, 21 CFR Part 11 and EU Annex 11) and industry standards (e.g., GAMP 5).
• Experience in technical writing for cGMP documents.
• Experience in writing & reviewing SOPs and protocols for accuracy and compliance.