Location: Tarrytown,NY, USA
Position
Senior Manager, Quality Assurance (Tarrytown, NY)
Department:
Operations
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 one of the largest independent providers 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 & Regulatory Affairs 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) and ophthalmic medical devices. 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 at Contractors and internal stakeholders such as Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning and Logistics.
MAJOR RESPONSIBILITES/ACTIVIES:
* Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance. Achieve QA operational objectives by acting as the point of contact for Quality matters for assigned sterile eyecare brands and/or Contractors.
* Supervise Quality Associates.
* Achieves QA operational objectives by acting as the point of contact for Quality matters for assigned brands and/or Contractors.
* Lead QA strategy for assigned brands by studying product requirements; analyzing options for product stability and process validation; recommending, preparing, and presenting corrective action plans; contributing information and opinion to cross-functional teams; preparing implementation plans and timelines.
* Supports new product introductions from a Quality perspective. Reviews and approved 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. 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.
* 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 ophthalmics and aseptic processing; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
* Accomplishes organization goals by accepting ownership for accomplishing new and different requests, exploring opportunities to add value to job accomplishments.
QUALIFICATIONS:
* 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 opthalmics with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control in a cGMP environment.
* 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.
* Experience with SAP or other similar ERP systems.
* Knowledge of IT validations to support a GMP environment
* 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.
Travel: 25% ability to travel via car, plane, rail.
LANGUAGE SKILLS:
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.
MATHEMATICAL SKILLS:
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.
REASONING ABILITY:
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.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
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: $150,000 - $170,000
Work Hours: 40 hours.
Prestige is an Equal Opportunity Employer
Search Firm Representatives - Please read carefully:
PRESTIGE CONSUMER HEALTHCARE does not accept unsolicited assistance from search firms. Please, no phone calls or emails. All resumes sent by search firms to any employee at Prestige Consumer Healthcare via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Prestige Consumer Healthcare. No fee will be paid in the event the candidate is hired by Prestige Consumer Healthcare as a result of the referral or through other means. Thank you for your cooperation.