The Associate Director of Quality reports to the Vice-President, Quality. The Associate Director oversees evaluations, tracking, trending, and monitoring of the Quality activities in a 503B outsourcing facility. The position provides support in assuring that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance/control, attention to detail, and excellent communication with other functional areas and sites.
Essential Functions:- 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 improvs 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
- Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends 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
- Other duties as assigned.
Supervisory Responsibilities:- Directly hire and lead a team of managers.
- Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
- Conduct regular 1:1'sto address performance, feedback and relationship building.
- Identify training and development needs within the team and facilitate as able.
Experience and Necessary Skills:- Bachelors in a related field is required (scientific discipline preferred) and/or equivalent experience.
- 5+years of comprehensive quality experience required (within 503B highly preferred).
- 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
- Ability to identify potential adverse issues
- Excellent organization and documentation skills
- Proven experience with strong leadership, communication, and relationship-building skills across teams and departments
- Ability to think strategically while driving operational execution and continuous improvement
- Proficiency in using sound judgment, data, and problem-solving skills to support business decisions and organizational goals
- Proven experience with change management, talent development, and accountability.
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements:- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
Benefits: - Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- FSA & HSA available
- Dental & Vision insurance options
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for Annual Bonus Program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
