Talent.com
Vice President, Quality Assurance & Regulatory Affairs (Tarrytown, NY)

Vice President, Quality Assurance & Regulatory Affairs (Tarrytown, NY)

Prestige Brands, Inc.Village of Tarrytown, NY, United States
30+ days ago
Job type
  • Full-time
Job description

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 Vice President (VP), Quality Assurance and Regulatory Affairs will report to the Chief Executive Officer and will ensure the regulatory and quality compliance of Prestige products throughout the ir life cycles and will monitor regulatory and quality developments potentially affecting the business.

The VP will also lead Medical Affairs activities including clinical studies, Customer Contact Center, and pharmacovigilance. Product categories include OTC monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements, and EPA-registered products.

The VP, Quality Assurance and Regulatory Affairs will design, implement, and monitor effective compliance strategies that align with the Company's business goals.

The VP has a solid over the counter (OTC) healthcare Quality and Regulatory Affairs background and will assure that all products and contractors meet the applicable quality and regulatory requirements. The VP will develop strategy that supports all brands and new products as well as operational initiatives.

MAJOR RESPONSIBILITES / ACTIVIES :

  • The VP, Quality Assurance and Regulatory Affairs serves as a management representative.
  • The VP, Quality Assurance and Regulatory Affairs will direct and oversee the Company's Quality Assurance, Regulatory Affairs, and Medical Affairs organization to lead the development and implementation of the Company's compliance strategies for its complete portfolio of products.
  • The VP, Quality Assurance and Regulatory Affairs serves as the Quality Representative (QR) and Management Representative (MR) including :

ensuring that quality management system requirements are effectively established, documented, implemented, and maintained and meet customer requirements;

  • reporting to top management on the performance and effectiveness of the quality management system and any need for improvement;
  • ensuring the promotion of awareness of applicable quality system and regulatory requirements throughout the organization; and
  • acting as liaison with external parties on matters relating to the Quality Management System.
  • The VP, Quality Assurance and Regulatory Affairs will foster close cooperative relationships with all functions in the company relative to compliance, working with Marketing, Product Development, Package Development, Legal, and Operations to execute all product and labeling claims and strategies for the company’s brands.
  • The VP will lead and apply Quality Assurance and cGMP expertise for OTC drug products (monographed and NDA / ANDA), medical devices, dietary supplements, and cosmetics.
  • The VP will confirm the cGMP compliance of third-party contract manufacturers (Contractors) by developing and executing Prestige Consumer Healthcare' Quality Assurance programs to ensure the marketing of safe, stable, and legal product.
  • The VP will maintain New Drug Applications, 510Ks, and other regulatory documentation for all products.
  • The VP will monitor global Regulatory and Quality developments affecting Prestige products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues within the organization.
  • The VP will provide clear direction to Medical Affairs on clinical studies, the Customer Contact Center, and pharmacovigilance.
  • QUALIFICATIONS :

    Minimum Requirements EDUCATION / CERTIFICATION :

  • Bachelor's Degree in Scientific or health related field; master’s degree preferred
  • REQUIRED KNOWLEDGE :

  • Strong knowledge of US OTC NDA, monograph drug, and medical device regulatory requirements and submissions
  • Strong knowledge of FDA and FTC claims support requirements
  • Strong Knowledge of cGMP regulations and requirements in all aspects of manufacturing and distributing OTC drugs and medical devices
  • Strong Knowledge of ISO 13485 : 2016
  • Working knowledge of Canadian, EU, and Latin American regulations
  • Working knowledge of US clinical research methods
  • Excellent written and verbal communication skills
  • Demonstrated ability to work with people in an effective and positive manner
  • EXPERIENCE REQUIRED :

  • 20+ years of experience in US and Canada Quality Assurance and / or Regulatory Affairs in CPG industry; global experience a plus
  • NDA or 510(k) submission and / or maintenance experience
  • Demonstrated ability of supervising a team for 10+ years with a successful track record
  • Travel : 20% 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.

    S alary Range : $250,000 - $300,000; this range reflects a variety of factors including, but not limited to, candidate experience, qualifications, geographic location, and prevailing market conditions. Compensation also includes a discretionary annual bonus, long-term incentives, and a solid, well-rounded benefits package.

    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).

    Work Hours : 40 hours per week.

    #J-18808-Ljbffr

    Create a job alert for this search

    Vice President Quality Assurance • Village of Tarrytown, NY, United States

    Related jobs
    • Promoted
    Director, Clinical Quality Assurance

    Director, Clinical Quality Assurance

    EisaiNutley, NJ, United States
    Full-time
    Director, Clinical Quality Assurance page is loaded.Director, Clinical Quality Assurance.Apply remote type Hybrid Work Arrangement locations New Jersey, Nutley New Jersey, Newark New York, Brooklyn...Show moreLast updated: 3 days ago
    • Promoted
    Director, Global Regulatory Affairs, Growth Markets

    Director, Global Regulatory Affairs, Growth Markets

    EisaiManhattan, NY, United States
    Full-time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...Show moreLast updated: 2 days ago
    • Promoted
    Senior Vice President, Regulatory Affairs

    Senior Vice President, Regulatory Affairs

    Kaye / Bassman InternationalParsippany, NJ, United States
    Full-time
    Location : Hybrid - Parsippany, NJ (or) Brisbane, CA (Hybrid).My client is a commercial-stage leader in non-opioid pain management and regenerative health solutions. They are dedicated to transformin...Show moreLast updated: 8 days ago
    • Promoted
    Chief of Oncologic Quality

    Chief of Oncologic Quality

    RWJBarnabas HealthLivingston, US
    Full-time
    RWJBarnabas Health is seeking an experienced and dedicated.This physician leader will oversee, plan, and execute strategies to elevate patient outcomes, safety, and satisfaction while meeting natio...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Ob / Gyn Quality & Safety - NewYork-Presbyterian / Queens

    Director, Ob / Gyn Quality & Safety - NewYork-Presbyterian / Queens

    NewYork-PresbyterianQueens, US
    Full-time
    Department of Obstetrics and Gynecology is looking for a Board Certified .Director of Ob / Gyn Quality & Safety.This position incorporates inpatient & outpatient clinical work as well as...Show moreLast updated: 30+ days ago
    • Promoted
    VP, P5, Regulatory Relations : Job Level - Vice President

    VP, P5, Regulatory Relations : Job Level - Vice President

    Morgan StanleyNew York, NY, US
    Full-time
    Vice President, Regulatory Relations.Professionals within Legal and Compliance provide a wide range of services to our business units. They might help to structure a complex and sensitive cross-bord...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Quality Improvement

    Director of Quality Improvement

    Saint Joseph's Medical Center / St. Vincent's Hospital Westchester DivisionYonkers, NY, United States
    Full-time
    Under the direction of the Vice President and Chief Quality Officer, the Director of Quality Improvement is responsible for developing and implementing the organization’s Performance Improvement pl...Show moreLast updated: 30+ days ago
    • Promoted
    Vice President for Enrollment Management

    Vice President for Enrollment Management

    InsideHigherEdCaldwell, New Jersey, United States
    Full-time
    Caldwell, New Jersey and founded by the Sisters of Saint Dominic of Caldwell, is seeking a Vice President for Enrollment Management to lead innovation and strategy within the enrollment, retention,...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Licensed Therapist (LCSW, LMHC, LMFT) - Tomkins Cove, NY

    Licensed Therapist (LCSW, LMHC, LMFT) - Tomkins Cove, NY

    LifeStance HealthTomkins Cove, NY, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 3 hours ago
    • Promoted
    President

    President

    InsideHigherEdGarden City, New York, United States
    Full-time
    Adelphi University seeks nominations and applications for its 11.Founded in 1896, Adelphi University is Long Island’s oldest private, coeducational institution of higher learning and one of the reg...Show moreLast updated: 30+ days ago
    • Promoted
    Vice President of Quality, Behavioral Health

    Vice President of Quality, Behavioral Health

    Northwell Health Physician PartnersQueens, US
    Full-time
    Young, Chair and Senior Vice President of Behavioral Health and Dr.Manish Sapra, Executive Director of Northwell Health’s Behavioral Health Service Line, with the support of Northwell Executive Lea...Show moreLast updated: 22 days ago
    • Promoted
    Vice President Strategy Director

    Vice President Strategy Director

    Health And Wellness PartnersSaddle Brook, NJ, US
    Full-time
    Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advanc...Show moreLast updated: 19 days ago
    • Promoted
    Chief of Oncology Quality

    Chief of Oncology Quality

    AMN HealthcareWest Orange, US
    Full-time
    Job Description & Requirements.StartDate : ASAP Pay Rate : $750000.An opportunity to join a large, supportive organization, this Chief of Oncology Quality role is in one of New Jersey’s top suburbs.A...Show moreLast updated: 30+ days ago
    • Promoted
    Director - Quality and Regulatory Compliance CCS (Comprehensive Cell Solutions) - Rye, NY

    Director - Quality and Regulatory Compliance CCS (Comprehensive Cell Solutions) - Rye, NY

    New York Blood CenterRye, NY, United States
    Full-time
    Director - Quality and Regulatory Compliance CCS (Comprehensive Cell Solutions) - Rye, NY.The Director, Quality and Regulatory Compliance (CCS) leads quality, compliance, and regulatory initiatives...Show moreLast updated: 1 day ago
    • Promoted
    Vice President, Quality Assurance & Regulatory Affairs (Tarrytown, NY)

    Vice President, Quality Assurance & Regulatory Affairs (Tarrytown, NY)

    Prestige BrandsVillage of Tarrytown, NY, United States
    Full-time
    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 customer...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

    Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

    PharmaEssentiaNew York, NY, United States
    Full-time
    Associate Director, Pharmacovigilance Quality & Compliance (PVQA).It’s not often you get the chance to make a real impact on the lives of others while expanding your own possibilities.You’ll find t...Show moreLast updated: 11 days ago
    • Promoted
    Securities Services – Regulatory Practice Americas Manager – Vice President

    Securities Services – Regulatory Practice Americas Manager – Vice President

    JPMorganChaseNew York, NY, United States
    Full-time
    Morgan, a global leader in financial services, where collaboration and innovation drive outstanding solutions for our clients. Be part of the dynamic Global Regulatory Practice team, which spans Eur...Show moreLast updated: 6 days ago
    • Promoted
    Trauma Medical Director / Acute Care Surgeon

    Trauma Medical Director / Acute Care Surgeon

    Northwell Health Physician PartnersMount Kisco, US
    Full-time
    Northwell Health is seeking a full-time academic Trauma Medical Director / Acute Care Surgeon BE / BC in Surgical Critical Care / Trauma Surgery to join the faculty at our Northern Westchester campus (in...Show moreLast updated: 30+ days ago