Associate Director of Quality

About the role

The Associate Director of Quality reports to the Vice-President, Quality. The position oversees evaluations, tracking, trending, and monitoring of the Quality activities in a 503B outsourcing facility, ensuring the drug product meets safety, identity, strength, quality, and purity standards. The role requires an individual with a deep understanding of cGMP requirements, who can work independently and collaboratively.

Responsibilities

• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Support the VP Quality in ensuring compliance with regulatory and procedural requirements while providing backup.
• Assist with meeting financial objectives by assisting with estimation requirements; supporting preparation of annual budgets.
• Develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
• Oversee Quality Risk Management by preparing quality documentation and reports, including failed processes, stability studies, recalls, corrective actions, and re-validations; update job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
• Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control.

Requirements

• Bachelor's degree in a related field (scientific discipline preferred) or equivalent experience.
• 5+ years of comprehensive quality experience required (preferably in a 503B setting).
• 3+ years of experience leading people.
• Working knowledge and experience with US FDA cGMPs, preferably in a commercial compounding outsource facility.
• Working knowledge and experience of compounding techniques, controlled environments, and compounding facilities.
• Working knowledge of appropriate materials and conditions.
• Excellent organization and documentation skills.
• Proven experience with strong leadership, communication, and relationship-building skills across teams and departments.
• Proven experience with change management, talent development, and accountability.
• Proficiency in using sound judgment, data, and problem-solving skills to support business decisions and organizational goals.
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft Office, and Excel.

Qualifications

• Experience with cGMPs, preferably in a commercial compounding outsource facility.
• Knowledge of compounding techniques, controlled environments, and compounding facilities.
• Understanding of appropriate materials and conditions.
• Strong organizational and documentation skills.
• Effective leadership, communication, and relationship-building skills.
• Strategic thinking and operational execution skills.
• Problem-solving and data analysis skills.
• Leadership and development of teams.
• Use of Microsoft 365 tools.

Skills

• Comprehensive quality experience.
• Leadership and management skills.
• Communication and collaboration skills.
• Change management and talent development.
• Data analysis and problem-solving skills.
• Use of Microsoft 365 tools.

Benefits

• Social Security and Medicare coverage.
• Flexible spending accounts (FSAs) and health savings accounts (HSAs).
• Dental and vision insurance options.
• Employer-paid life insurance and employee assistance program.
• Short-term and long-term disability insurance.
• Up to 4% 401(k) matching (100% vested on day one!)
• Annual tuition reimbursement after 6 months.
• Referral bonus program with no limit.
• Annual bonus program.