What are the responsibilities and job description for the Director of Quality & Regulatory Compliance position at Annovex?
About Annovex Pharma, Inc
Annovex Pharma, the sole 503B Outsourcing Facility in Virginia and the DMV area, is expanding. In line with our motto "Uncompromising Quality, Reliability and Service," we are committed to providing superior compounded sterile and non-sterile pharmaceuticals, prioritizing innovation, integrity, accountability, fairness, and enjoyment.
Annovex Pharma, Inc benefits include health care, life insurance, AD&D, paid time off, retirement savings and professional development. Employees can also take advantage of several corporate discounts.
About the role
We are hiring a full-time Director of Quality & Regulatory Compliance to lead our Quality Assurance and Quality Control (Quality Unit) team at our Lorton, Virginia facility. This leadership role involves managing product quality, ensuring compliance with DEA / FDA regulations, cGMP standards, and overseeing training and departmental programs.
Responsibilities include maintaining GMP compliance, SOP adherence, and overseeing various operations like material handling, aseptic cleaning, inspection, labeling, packaging, warehousing, shipping, and testing.
The ideal candidate should have experience managing a Quality Unit and a strong understanding of cGMP, with excellent communication skills necessary for organizational interaction.
Join Annovex Pharma and help us succeed!
What you'll do
The successful candidate will :
- Lead and guide a team of Quality professionals; develop and expand the team to meet changing business demands, accountable for Quality Assurance and Microbiology Quality Control.
- Oversee budgeting, staffing, and organizational development of the Quality team, including establishing mentoring and coaching programs.
- Ensure a strong cGMP Quality Culture is set up and sustained.
- Provide advice and expertise in interpreting Good Manufacturing Practice guidelines and regulations.
- Guarantee that all products manufactured at the site are produced, tested, and released compliant with SOPs, cGMPs, FDA, and DEA requirements.
- Supervise key quality systems (e.g., Deviation, Change Control, and CAPA) by monitoring status, progress, and reporting Key Quality Indicators (KQIs) to site leadership.
- Continuously improve and implement the Incoming Quality Assurance (IQA), Manufacturing Quality Assurance (MQA), and Batch Record Release (BRR) programs as needed.
- Ensure Annovex's SOPs, Batch Records, and Forms comply with cGMPs, cGDPs, and align with other policies and procedures.
- Offer guidance during investigations to ensure accurate root cause determination and corrective actions.
- Review and approve internal audits, supplier complaints, and customer complaints.
- Drive continuous improvement initiatives to enhance compliance, productivity, cost-effectiveness, and efficiency of processes related to Quality.
- Lead the site inspection readiness program.
- Make batch rejection decisions and manage recall decisions with the Site Leadership Team.
- Conduct regulatory inspections and customer Audits.
- Promptly communicate critical cGMP and / or non-compliance issues to the leadership team.
- Seek opportunities to identify change, boost efficiency, influence decisions, and deliver results while ensuring compliance.
- Stay updated with regulatory guidance relevant to the 503B and pharmaceuticals outsourcing sector.
- Act as a member of the site leadership team, engaging in business decision-making from a quality stance.
The successful candidate will :
Qualifications
Required :