Director, Quality Assurance (Compliance)

Overview

Director, Quality Assurance (Compliance) at Granules Pharmaceuticals, Inc. located in Chantilly, VA. This is an on-site position.

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Responsibilities

• Provide leadership and direction regarding cGMP Compliance at the Chantilly site to ensure adherence to applicable regulations.
• Maintain excellent knowledge of the 21CFR, ICH, and USP to interpret and apply regulations related to cGMP operations at the Chantilly site.
• Represent the department during high-level discussions and investigations with external customers, vendors, and FDA representatives.
• Lead as the site Quality representative during FDA inspections.
• Lead site inspections conducted by external regulators and business partners.
• Conduct Compliance GAP analyses with recommendations for gap closure and follow-up effectiveness checks.
• Implement and track site-wide remediation and improvement plans based on quality metric assessments.
• Maintain site quality metrics and analyze data to sustain compliance.
• Build and manage effective systems, processes, and cross-functional teams to manage site compliance.
• Manage and develop direct reports by setting clear expectations and resolving conflicts.
• Ensure adherence to company protocols and timely closure of deviations from procedures or cGMP requirements.
• Interface with different departments regarding quality issues, audits, and special projects.
• Provide guidance to manufacturing regarding quality cGMP issues to ensure compliance with applicable standards and regulations.
• Provide technical expertise for personnel training, deviations, CAPA, inventory management, cGMP compliance, and data trending.
• Review and approve, as required, OOS, SOPs, protocols, and investigations.
• Coordinate and supervise the collection of data reported in the product review.
• Prepare, as required, and review documentation required for regulatory submissions.
• Serve on the Quality Task Force and participate in the generation and review of company standard operating procedures.
• Ensure the site remains current with changes to applicable compendia, regulations, and guidance.
• Manage direct reports, including training and development to stay abreast of current cGMP compliance technology.

Minimum Experience & Education

• BA/BS in Biochemistry, Chemistry or related field; MS/MA preferable
• 13+ years of experience in Quality within the biotech or pharmaceutical industry, with OS D manufacturing highly preferred
• 5+ years experience in a leadership position within Quality

Required Knowledge & Skills

• Knowledge of 21CFR, ICH, USP and other regulatory requirements and standards.
• Experience managing and hosting regulatory inspections.
• Ability to maintain integrity and honesty at all times.
• Ability to communicate and lead with transparency.
• Leadership in optimizing department performance and driving future improvements.
• Accountability for department performance and results.
• Management experience required.

Reports to

Global Quality Head

Employment type

Full-time

Seniority level

Director

Job function

• Quality Assurance
• Industries
• Pharmaceutical Manufacturing

US Based Candidates Only

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