Granules Pharmaceuticals, Inc.
Director, Quality Assurance (Compliance)
Granules Pharmaceuticals, Inc., Chantilly, Virginia, United States, 22021
Overview
Director, Quality Assurance (Compliance)
at Granules Pharmaceuticals, Inc. located in Chantilly, VA. This is an on-site position. Join to apply for the
Director, Quality Assurance (Compliance)
role at
Granules Pharmaceuticals, Inc. 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
#J-18808-Ljbffr
Director, Quality Assurance (Compliance)
at Granules Pharmaceuticals, Inc. located in Chantilly, VA. This is an on-site position. Join to apply for the
Director, Quality Assurance (Compliance)
role at
Granules Pharmaceuticals, Inc. 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
#J-18808-Ljbffr