Senior Manager, Quality Assurance - Sterile Eye Care

Prestige Brands-posted 17 days ago

$150,000 - $170,000/Yr

Full-time • Mid Level

Hybrid • Tarrytown, NY

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Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere. JOB SUMMARY: The Quality Assurance (QA) Sr. Manager will hold a key position in our Quality Department. This individual will support existing products and new product introductions in sterile eyecare by providing and applying Quality Assurance and cGMP expertise for OTC sterile ophthalmic drug products (monographed), ophthalmic medical devices and other assigned brands as applicable. The individual will also ensure GMP compliance of third-party contract manufacturers (Contractors) by developing and executing Prestige Brands’ Quality Assurance programs. The individual must develop and maintain an effective working relationship with QA personnel and technical experts at Contractors and internal stakeholders such as Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning and Logistics.

Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance.
Supervise Quality Associates.
Achieves QA operational objectives by acting as the point of contact for Quality matters for assigned sterile eyecare brands and/or Contractors and the evaluation of new manufacturing equipment to support sterile aseptic processing and filling.
Lead QA strategy for assigned brands by studying product requirements for aseptic processing and filling; analyzing options for product stability and process validation; recommending, preparing, and presenting corrective action plans; reviewing nonconformances and the ability to conduct a risk assessment; contributing information and opinion to cross-functional teams; preparing implementation plans and timelines.
Supports new product introductions from a Quality perspective. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to Contractor. These include but are not limited to aseptic processing, 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 the effectiveness of Contractors’ quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing Contractor response adequacy and timeliness, determining system improvements. Escalates all serious cGMP and regulatory compliance issues to department leadership with appropriate risk assessment & recommendations. Coaches Contractors where quality systems are deficient; drive 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.
Prepares reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as Stability, Complaints, Nonconformance Reports, Deviations, Investigations, CAPA for Annual Product Reviews.
Protects organization’s competitiveness by keeping information confidential.
Maintains professional and technical knowledge by tracking national and international regulatory/governmental developments related to sterile ophthalmic and aseptic processing; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Accomplishes organizational goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

Minimum of BS in a Scientific discipline, microbiology preferred
15 years QA experience in pharmaceutical industry (OTC preferred) and at least 5 years in sterile aseptic processing with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control in a cGMP environment.
Working knowledge of EU GMP Annex 1 for sterile pharmaceutical manufacturing and the use of barrier technologies like isolators and Restricted Access Barrier Systems (RABS) to reduce human intervention and protect sterile products from contamination.
Experience with leading and managing cGMP audits.
Demonstrated sound decision-making process and scientific problem-solving capabilities based on facts, data, and the application of risk management principles.
Proven track record of managing multiple responsibilities with a consistent sense of urgency.
Proven track record of managing individuals.
Experience with SAP or other similar ERP systems.
Ability to lead a project and work independently with a high sense of urgency.
Ability to analyze information.
Outstanding verbal and written communication skills and demonstrated interpersonal skills.
High proficiency in computer skills, Microsoft Office/Project.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.
Applicants must be authorized to work for ANY employer in the U.S.
All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).

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