• Lead the QA validation team, providing guidance, mentoring, and performance management.
• Develop and implement validation strategies and policies in alignment with company goals and regulatory standards (FDA, EMA, ISO, etc.).
• Collaborate with cross-functional teams, including manufacturing, engineering, R&D, automation, and regulatory affairs, to ensure validation plans meet business objectives.

Validation Process Oversight:
• Oversee the development, execution, and review of validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Ensure detailed and compliant validation documentation, including risk assessments, protocols, and final reports.
• Maintain validation master plans, timelines, and metrics to supervise progress and compliance.

Regulatory Compliance:
• Ensure all validation activities and procedures are in compliance with applicable regulatory requirements and internal quality standards (cGMP, GxP, etc.).
• Prepare for and represent the QA validation function during regulatory inspections and audits.
• Stay updated on industry trends and regulatory changes to ensure compliance and continuous improvement in validation processes.

Continuous Improvement:
• Identify areas for process improvements in validation practices, implementing changes to improve efficiency, compliance, and effectiveness.
• Participate in root cause analysis for validation deviations and non-conformances, developing corrective and preventive actions (CAPAs).

Risk Management:
• Conduct risk assessments related to validation activities and ensure proper mitigation strategies are in place.
• Work with the quality and engineering teams to assess the impact of process and equipment changes and determine re-validation requirements.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
• Minimum of 8-10 years of experience in Quality, Validation or equivalent within the pharmaceutical, biotech, medical device, or related regulated industries.
• Proven leadership experience developing teams and projects.
• Strong understanding of validation principles, including equipment, process, and computer system validation.
• Detailed knowledge of cGMP, FDA, EMA, ISO, and other regulatory requirements related to validation.
• Excellent project management skills with the ability to manage multiple projects simultaneously.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

Preferred Skills:
• Experience with statistical methods and risk-based validation approaches.
• Familiarity with software validation and 21 CFR Part 11 compliance.
• Experience in lean manufacturing and continuous improvement methodologies (e.g., Six Sigma, Lean).

Work Environment:
• Office and manufacturing environments.
• Occasional travel may be required for audits, vendor meetings, or regulatory inspections.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!