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Job Summary
The Sr. Manager, Quality Assurance, is a key member of the Quality & Regulatory Affairs team responsible for ensuring the quality, compliance, and continuous improvement of Prestige Consumer Healthcare's medical device and OTC drug product portfolio. This role serves as the primary Quality Assurance lead for assigned brands and contract manufacturing partners, providing strategic quality oversight throughout the product lifecycle, from new product development and commercialization through ongoing manufacturing and post-market support.
This role will apply Quality Assurance, cGMP, and risk management expertise to support existing products and new product introductions while ensuring compliance with applicable FDA regulations, ISO standards, and other global quality requirements. The role is responsible for evaluating and strengthening contract manufacturing partners’ quality systems, leading quality audits, managing quality agreements, and driving resolution of quality and compliance issues.
Success in this position requires strong cross-functional collaboration with internal stakeholders, including Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics, as well as the ability to influence quality outcomes across a network of third-party manufacturing partners.
Major Responsibilities/Activities
- Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance.
- Oversee the application of risk management (ISO 14971) and design controls throughout the medical device product lifecycle.
- Establish, implement, and maintain comprehensive policies and Standard Operating Procedures (SOPs) that comply with ISO 13485, FDA 21 CFR Part 820, and EU MDR guidelines.
- Achieve QA operational objectives by acting as the point of contact for quality matters for assigned brands and/or contract manufacturing partners.
- 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.
- Drive continuous improvement initiatives across contract manufacturing partners quality systems to enhance compliance, efficiency, and product quality.
- Identify and mitigate quality and compliance risks through the application of risk management principles and proactive quality oversight.
- Provide strategic quality leadership and recommendations to cross-functional teams supporting product development, commercialization, and lifecycle management.
- Support new product introductions from a Quality perspective. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to contract manufacturing partners. These include but are not limited to 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.
- Evaluate the effectiveness of contract manufacturing partners quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing contract manufacturing partners response adequacy and timeliness; determining system improvements. Escalates all serious cGMP and regulatory compliance issues to department leadership. Coaches contract manufacturing partners where quality systems are deficient; drive remedial action where necessary.
- Define the quality obligations and responsibilities of contract manufacturing partners by preparing, negotiating, and reviewing Quality Agreements.
- Provide leadership, guidance, and influence across cross-functional teams and external manufacturing partners to ensure quality, compliance, and business objectives are achieved.
- Assure the quality of commercial product by reviewing and approving contract manufacturing partners design control, change controls, deviations, nonconformances, and out of specification investigations. Initiates and conducts internal change controls, planned deviations, and investigations where applicable.
- Prepare 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.
- Protect organization’s competitiveness by keeping information confidential.
- Maintain professional and technical knowledge by tracking national and international regulatory/governmental developments; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
- Accomplish organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
QUALIFICATIONS:
- Minimum of a Bachelor's degree in scientific discipline.
- 8+ years of Quality Assurance experience within medical devices and/or pharmaceutical manufacturing environments.
- Knowledge of FDA 21 CFR Parts 211 and 820, FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable medical device and pharmaceutical quality requirements.
- Experience supporting medical device quality systems, design controls, and risk management activities is preferred.
- 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.
- Excellent written and verbal communication skills with superior attention to details.
- Strong interpersonal and communication skills to effectively work with people at all levels.
- Excellent organizational skills with ability to handle changing priorities in a fast-paced environment and able to adjust workload based on changing priorities.
- Ability to work in a team environment as well as independently with minimal supervision.
- Proficient with Microsoft Office products including Word, Excel, and Power Point.
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 accommodation 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 accommodation 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).
Work Hours: 40 hours per week.
Compensation Range: $150,000.00 - $175,000.00 annually
