Director of Quality Assurance

We are seeking a highly motivated and experienced Director of QA to join our team. In this role, you will be responsible for ensuring GMP compliance for our facility and equipment. You will play a critical role in ensuring the quality and safety of our products, while also ensuring that our operations comply with relevant regulations and standards.

The ideal candidate is sharp, self-motivated, and an effective communicator. Our working environment is dynamic and evolving and the ideal candidate has a strong capability to problem solve, drive change, work well cross functionally and liaise with our customers.

Responsibilities: but not limited to:

• Plan and perform internal & external audits (raw material, printed and non-printed components, contract labs/manufacturers) against GMP regulations, or other appropriate regulations as standards
• NSF GMP and customer audits and expert on NSF guidelines
• Schedule, host and respond to regulatory, customer, and certification audits
• Oversee the Foreign Supplier Verification Program
• Manage the document control team – master and production batch record retention, release bulk and finished product to market
• Oversee the following programs – pest control, environmental monitoring, metrology, change control, investigations, GMP and SOP training, CAPA, Quality Review Board, Material Review Board, product returns, withdrawals and recalls
• Lead investigation, root cause analysis, and escalation of quality issues to ensure timely and effective issue resolution
• Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards, lot disposition, and procedures when necessary
• Ensure compliance with all relevant quality policies, regulations, and procedures
• Prepare and/or participate in customer, contractor and supplier Quality Agreements
• Prepare and/or approve Annual Product Reviews
• Other responsibilities as assigned by executive management

Qualification and Education:

• Experienced in SOPs, Reports and Document Control (5 years)
• Experienced in Complaint Handling, CAPA, NCMR (3-5 years)
• Experience dealing with Regulatory Affairs (2 -3 years)
• Coordinating outside contract laboratories as well as ISO certifications and reassessments
• Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal / external cGMPs, GLP, CFR, CFR 111
• Bachelor’s degree but master’s degree preferred 10 years of GMP managerial experience within pharmaceutical quality assurance and compliance; minimum 3 years’ experience as a lead auditor
• Design, implement and modify standards and procedures to improve workflow
• Work closely and effectively with a diverse group of senior leaders as well as peers and subordinates
• Excellent interpersonal, management and organizational skills
• Demonstrated ability to build and motivate a high performing team
• Demonstrate the highest level of work ethic and discretion given confidentiality of information
• High level of organization and attention to detail ensuring product accuracy and documentation compliance
• Team orientated and highly collaborative
• Proficient in MS Office and SAP
• Fluent in English and other countries languages preferred.

Physical Demands:

• Required to reach with arms and use hands and fingers to handle or feel objects and tools
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders
• Must be able to lift and/or move up to 10 pounds with the possibility to 50 pounds

We offer a comprehensive benefit package including medical, dental, vision, and 401K with match.

If you are excited to join our company and take the next step in your career, click the apply now button to find out more.

Compliance with New York State Human Rights Pay Transparency Law, the annual base salary range for this position is $100k-$150k. Please note that the salary information is a general guideline only. AHF considers factors such as (but not limited to) scope and responsibilities of the position, candidate’s work experience, education/training, key skills, internal peer equity, as well as market and business considerations when extending an offer.

The Company

American Health Formulations is a fast-growing contract development and manufacturer of Dietary Supplements, Medical Foods, Herbal and OTC Products. We offer end to end services from R&D, custom formulation development, to production, packaging, and in house testing. We are experienced in the Nutraceutical, Pharmaceutical, Food and Beverage, and Cosmetic industries. We are FDA registered, operate under NSF, cGMP guidelines, and licensed as a New York State Food Processing facility. Come work with us – we are dedicated to making our customers ideas a reality.

We are an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit and business need.