Director, Quality Assurance (Compliance)

Description

• US Based Candidates Only**
  
  

Granules Pharmaceuticals, Inc., located in Chantilly, VA was the 10th fastest growing generic pharma company in United States in 2024 based on sales growth! We manufacture dosage forms with specific release capabilities 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, all supported by our API business. Granules is one of the few pharmaceutical companies to be vertically integrated from API to packaging.

As a Director, QA Compliance, you will be accountable for the leadership activities and to direct all facets of Quality Compliance including, but not limited to, managing Quality Systems (incidents resolution, CAPAs, change control, complaints resolution), host FDA inspections and respond to questions arising from the inspections, oversee remediation activities for site-wide compliance improvements, external and internal audits, training with effectiveness checks, Quality metrics, data trending and evaluation with recommendations for cGMP Compliance improvements. Additionaly, you will ensure sustainable cGMP compliance, participate with regulatory bodies to address questions, and act as the lead for drafting responses to FDA Form 483 observations.

The Director, QA Compliance, will provide regular monthly updates to senior management regarding the progress and status of cGMP Compliance.

This is an on-site position.

• 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.
  
  

Requirements

Reports to

Global Quality Head

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, specifically with OSD Manufacturing highly preferred
• 5 years experience in leadership position within Quality
  
  

Required Knowledge & Skills

• 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
  
  

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.