What are the responsibilities and job description for the Associate Director- Quality position at Belmar Pharma Solutions?
POSITION OVERVIEW
The Associate Director of Quality is a key leader within our growing hormone replacement therapy (HRT) sterile product manufacturing facility. This role provides both strategic direction and hands-on execution of all quality activities to ensure the company’s products meet FDA, GMP, and safety standards. The Associate Director oversees quality systems, batch record review, laboratory coordination, quality control, complaint handling and quality operations. This position requires the ability to work independently, prioritize effectively, and build foundational processes that support future growth. The Associate Director of Quality reports to the Director of Quality.
RESPONSIBILITIES
Direct Supervision of Quality Leaders in Quality Assurance and Quality Control.
Helping build a culture of compliance, operational discipline, and continuous improvement across the small startup team.
Acting as a collaborative partner with Operations, R&D/Production Management, Process Engineering, Supply Chain, and Executive Leadership.
Defining Quality team objectives to ensure business deliverables are met.
Establishing, maintaining, and continuously improving the Quality Management System (QMS) suitable for a small pharmaceutical manufacturing environment.
Creating and managing SOPs, policies, work instructions, product specifications, and master batch records specific to HRT pellet production.
Ensuring compliance with applicable regulations, including FDA 21 CFR Parts 210–211, 503B Guidance for Industry.
Maintaining quality documentation and ensuring timely closure of deviations, investigations, CAPAs, complaints and change controls.
Representing Quality in FDA and State Board(s) of Pharmacy inspections.
Ensuring deviations, investigations, CAPA are closed in a timely manner.
Reviewing/approving complaints, deviations, investigations, CAPA, validations, SOPs/WIs/FORMs, protocols
Performs other duties as assigned.
PHYSICAL REQUIREMENTS
Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
Must be able to wear required PPE for long periods of time when required.
Position may require handling of laboratory chemicals or hazardous materials.
Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned.