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Prestige Consumer Healthcare · 1 month ago

Senior Manager, Quality Assurance - Sterile Eye Care

Tarrytown, NY

Full-time

Hybrid

Senior Level, Lead/Staff

$150K/yr - $170K/yr

15+ years exp

Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the healthcare sector. The Quality Assurance Sr. Manager will oversee quality assurance for sterile eyecare products, ensuring compliance with cGMP and supporting new product introductions.

Health CareMedicalPersonal HealthPharmaceutical

No H1B

Responsibilities

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

Qualification

Quality AssuranceCGMP complianceSterile aseptic processingEU GMP Annex 1CGMP auditsSAPERP systemsScientific problem-solvingMicrosoft Office/ProjectDecision-makingInterpersonal skills

Required

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