Associate Manager/Manager, Quality Assurance

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

The QA Manager ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing documentation for all quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

Job Duties & Responsibilities

• The person will be responsible for managing and ensuring that facility meets all GMP, FDA and SOP requirements.
• Managing all quality operations to include inspection of components, bulk, and final products for the Chantilly, VA, ensuring release lead times are met with timely product disposition.
• Ensure that the facility is meeting all training requirements.
• Lead the communication of open quality document notification and resolution between all departments regarding Complaints, Investigations, Change Control, CAPA’s (including verification of CAPA’s) and other quality documents as needed.
• Manage and maintain audit inspections (Internal and External) for the site.
• Responsible for supporting the preparation, review, processing, and approval of various validation documents as application for the Granules, Chantilly, facility.
• Provide QA support, review and approval for relevant documents including relevant procedures, batch records, specifications, stability reports, technical reports (i.e., Qualification, Validation, Transportation.), trend reports, Annual Product Quality Reviews and other documents as needed.
• Responsible for performance and development of all Quality Assurance staff through mentoring and focusing on personal and professional growth.
• Work with Quality leadership team for proactive succession planning and a high-performance culture through people.
• Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
• Provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement.
• Implementation Quality management system tools and their compliance.
• Development and execution of quality training modules for the organization.
• Ensure staff receives appropriate knowledge and skill development and growth opportunities
• Work with Regulatory Affairs to supply information needed for FDA filings.
• Other duties as assigned by management.