Quality Compliance Director

Job Description

The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe.

The Quality Compliance Director will be a core member of the West Point Quality Assurance Leadership Team and serves as a quality leader accountable for the quality oversight and management of the Quality team overseeing Regulatory Inspections, Site Internal Audit and Health Authority reporting supporting the West Point Manufacturing and Quality Control laboratories. The position will be responsible to ensure site’s compliance with applicable regulations, industry standards and Quality Management Systems. The incumbent will be responsible for developing, implementing and leading a group of compliance professionals through the deployment of compliance programs, monitor compliance efforts and advise site senior management on compliance related matters. The role also involves serving as the lead for regulatory agency inspection coordination and collaborating with other departments to address compliance issues. The responsibilities of this role will additionally include sustainment through continuous improvement of the organization at the site.

Primary activities include, but are not limited to:

• Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes leading the site audit program and inspection readiness team.

• Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.

• Champion engrained quality culture across the manufacturing site by enhancing learning and awareness of quality systems

• Conduct regular compliance risk assessments, identify potential risks and develop strategies to mitigate the risks. Identify and address compliance issues, develop corrective action plans and implement improvements to compliance programs

• Coach the site on quality risks to develop near and long term strategies with all operational related risks identified and escalation and mitigation of risks in a timely manner.

• Act as a liaison and/or SME to present operational compliance to Health Authorities and regulatory agencies on relevant topics.

• Lead a team of professionals who serve as contact for regulatory agencies during inspections, responding to inspectional or regulatory agency inquiries, providing information and addressing compliance concerns.

• Serve as lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.

• Health Authoring Reporting, including but not limited to BPDRs, DPRs, and FARs | Assesses events such as complaints and deviations and determines the need to report the event | Works with responsible teams to author and submit the required health authority notification and any follow-up action.

• Lead a team of site internal auditors to ensure PIR and monitor ongoing compliance activities

• Provide training and guidance to employees on compliance related matters, ensuring a robust PIR and auditing program at the site.

• Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launches

• Skills in engaging and collaborating with various functional teams (e.g., Operations, Technology, Automation, Regulatory, Research).

• Act as a partner to applicable network teams and communities of practice associated with compliance, facility fitness, inspection readiness, data integrity and other programs as applicable.

• Partner across Quality and other key stakeholders to ensure the monitoring of third party supplier’s compliance with requirements of cGMPs and applicable regulations.

• Ability to build relationships and work effectively in a team-oriented environment.

• Engage and drive continuous improvement initiatives across the site to drive simplification and standardization.

Minimum Education Requirements and Experience:

• Bachelor’s degree (BA/BS) with 10+ years of experience in leading large molecule Quality audit and technical inspectional strategies with adherence to FDA regulations within the biopharmaceutical or vaccine industries verifying GMP compliance.

Required Experience, Skills, a