Granules Pharmaceuticals, Inc. ยท 3 months ago
Director, Quality Assurance (Compliance)
Chantilly, VA
Full-time
Onsite
Director/Executive
13+ years expGranules Pharmaceuticals, Inc. is a rapidly growing generic pharma company specializing in dosage forms and drug release technologies. The Director, QA Compliance will lead Quality Compliance activities, manage Quality Systems, host FDA inspections, and ensure adherence to cGMP standards while providing updates to senior management.
Pharmaceuticals
No H1B
U.S. Citizen Only
Responsibilities
Provide leadership and direction regarding cGMP Compliance at the Chantilly site to ensure adherence to applicable Regulations
Excellent knowledge of the 21CFR, ICH, and USP to interpret and apply Regulations with respect to any questions related to cGMP Operations at the Chantilly site
Represents 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 the site in inspections conducted by external regulators and business partners
Conduct Compliance GAP analysis with recommendations for gap closure, implementation and follow up of effectiveness checks
Implement and follow through with site-wide remediation and improvement plans based on assessment of Quality metrics
Maintain Quality metrics for the site with analysis of data to sustain Compliance at the site
Responsible for building effective systems, processes and cross-functional teams to manage Compliance at the site
Manage and develop direct reports by setting clear expectations and resolving conflicts
Responsible to ensure adherence to company protocols and close in a timely manner any 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 all changes to applicable compendia, regulations and guidance
Manage direct reports, Responsibility includes training and developing direct reports to keep abreast of current technology as it relates to cGMP Compliance
Qualification
Required
BA/BS in Biochemistry, Chemistry or related field, MS/MA preferable
13 + years of experience in Quality within the biotech or pharmaceutical industry, specifically with OSD Manufacturing highly preferred
5+ years experience in leadership position within Quality
Knowledge of 21CFR, ICH, USP and other applicable regulatory requirements and standards
Manage and host Regulatory inspections
Ability to maintain integrity and honesty at all times
Ability to communicate and lead with transparency
Lead department for optimal performance and set course for future improvements
Accountable for performance and results of department
Management experience required
Company
Granules Pharmaceuticals, Inc.
Granules Pharmaceuticals, Inc. is a pharmaceuticals company based out of 3701 CONCORDE PKY, Chantilly, Virginia, United States.
Founded in 2014Chantilly, Virginia, US
51-200 employeesFunding
Current Stage
Growth StageLeadership Team
Gregory B. Reeves
Chief Human Resources Officer
Company data provided by crunchbase