Vice President, Quality Assurance & Regulatory Affairs (Tarrytown, NY) at Global Financial Impact - Edwin Alvarado

Tarrytown, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Mar, 26

Salary

300000.0

Posted On

04 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Affairs, Medical Affairs, cGMP Regulations, OTC Products, Clinical Studies, FDA Regulations, ISO 13485:2016, Team Supervision, Product Development, Compliance Strategies, Customer Contact Center, Pharmacovigilance, Contract Manufacturers, Global Regulations, Communication Skills

Industry

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 their lifecycles 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. Salary 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.

Responsibilities

The Vice President of Quality Assurance and Regulatory Affairs will ensure regulatory and quality compliance of products throughout their lifecycles and lead Medical Affairs activities. They will design and implement compliance strategies that align with the company's business goals and oversee the Quality Assurance, Regulatory Affairs, and Medical Affairs organization.