Quality Assurance Manager (Tarrytown, NY)

Summary Description:  Our Quality Assurance (QA) Manager holds a key position in our Quality Assurance and Regulatory Affairs department supporting existing products and new product introductions. Provides and applies quality assurance and cGMP expertise for our OTC medical devices, drug products (monographed and NDA/ANDA), dietary supplements, and cosmetics.  Emphasis on this particular role is on medical devices. Also ensures GMP compliance of third-party contract manufacturers (contractors) by developing and executing Prestige's Quality Assurance programs. 

#hybridwork. Work in the office on Tues/Weds/Thurs. Work from home on Mon/Fri.

Here are your essential duties and responsibilities:

• Acts as the point of contact for quality matters for assigned brands and/or contractors.
• Determines QA strategy for assigned brands by studying product requirements, identifying regulatory concerns, analyzing options for product stability and process validation, recommending, preparing, and presenting corrective action plans, contributing information and opinion to cross-functional teams, and preparing implementation plans and timelines.
• Supports new product introductions from an operational perspective. 
• Reviews and approves documentation associated with the introduction or transfer of a new or existing product to contractors including stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports. 
• Ensures that product dossiers are maintained and current.
• Evaluates effectiveness of contractor quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing contractor response adequacy and timeliness, and determining system improvements. 
• Escalates all serious cGMP and regulatory compliance issues to department leadership.
• Coaches contractors where quality systems are deficient; drives remedial action where necessary.
• Defines the quality obligations and responsibilities of contractors by preparing, negotiating, and reviewing quality agreements.
• Assures the quality of commercial product by reviewing and approving contractors’ change controls, deviations, nonconformances, and out of specification investigations.  Initiates and conducts internal change controls, planned deviations, and investigations where applicable.
• Collects, analyzes, and and prepares summary reports of regulatory and compliance data and trends such as stability, complaints, nonconformance reports, deviations, investigations, CAPA for annual product reviews.
• Protects competitiveness by keeping company information confidential.
• Maintains professional and technical knowledge by tracking national and international regulatory/governmental developments, attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, and participating in professional societies.
• Accepts ownership for accomplishing new and different requests; explores opportunities to add value to job accomplishments.

Here's what you need to qualify:

• a BS in a scientific discipline; Masters preferred
• 5-10 years' QA experience in pharmaceutical or medical devce industry with a thorough knowledge of quality systems, quality assurance, and quality control in a cGMP environment. 
• Experience leading and managing cGMP audits
• Analytical skills, sound decision-making processes and scientific problem-solving capabilities based on facts, data, and the application of risk management principles
• Ability to multitask, manage projects simultaneously and work independently
• Effective verbal and written communication skills; demonstrated interpersonal skills 
• High proficiency in computer skills, Microsoft Office/Project.

Here's what you can expect:

• We breathe new life into iconic brands finding creative ways to market our widespread portfolio of products; work that is fascinating and challenging
• Top notch health/welfare benefits with options to suit your needs; FSA or HSA savings plans too
• Solid company match on your 401(k) contribution,100% vested immediately
• Free parking and easy access from all Westchester highways and trains
• Employee-planned company outings 4+ times a year
• Our own in-house well-equipped gym, and showers with towels… available all day
• Freshly  brewed coffee & tea all day, and breakfast on us once a month
• Quarterly employee meetings with business updates
• Volunteerism encouraged and, on our Day of Caring.
• And most of all, we care for, trust and support each other so that we all succeed together.

No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

#HybridWork: We follow a Hybrid work schedule. All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).

Salary Range: 100K-130K and takes into consideration several factors including, but not limited to, experience, location, and market conditions.