The point where experts and best companies meet
West Pharma Senior Quality Manager United States, Michigan, Walker 616754308
29.06.2025
Share
Essential Duties and Responsibilities
- Directs and leads the Quality function for combination medicinal products, investigational medicinal products (IMP) and medical device products and components moulded, assembled, and packed by West, Grand Rapids to meet and exceed all regulatory requirements, customer requirements and key performance indicators.
- Serve as an internal subject matter expert in the development and execution of Quality Management System Compliance to Medical Device and Pharmaceutical regulations for Combination products and Drug Handling
- Deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
- In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
- Management representative responsible for the implementation and maintained integrity of the quality system
- Leads, develops, and executes on the local quality strategy for the Grand Rapids site, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing quality objectives.
- Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations.
- QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
- Direct and oversee the Quality Assurance, Quality Engineering, Quality Systems and Quality Program teams.
- Lead the engagement and interaction with key internal customers specifically Program Management, Operations, Engineering and Continuous Improvement teams and will be first point of contact for key strategic external customers.
- Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines
- Manage the customer satisfaction processes and lead improvements of overall customer satisfaction if discrepancies are identified.
- Directs Grand Rapids in line with Sister Site agreement requirements for products manufactured at other West sites.
- Leads regulatory agency interaction related to compliance to local and regional guidelines/ regulations and develops strong internal and external relationships with regulatory bodies and authorities
- Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
- Responsible and accountable for quality departmental budget
- Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and combination products.
- Direct and leads the facility readiness for all third part audits including notified bodies.
- Leads alignment and standardization of best practices and enterprise excellence across all West sites producing Customer or West owned platform devices.
- Play a role as a key contributor to Global Enterprise Quality documentation updating, including where appropriate, leading any updates
- Leads by example and sets the highest standards in employee engagement and communication to inspire innovation and quality excellence
- Other duties as assigned based on business needs
Education
- Bachelor's Degree required, preferably mechanical engineering, chemical engineering, manufacturing engineering, or industrial engineering
Work Experience
- Minimum 10+ years in medical device/pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
- Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements.
- Proven track record of implementing process improvements and ensuring compliance with regulatory standards.
Preferred Knowledge, Skills and Abilities
- In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements such as 21CFR Part 820 for Medical Devices and 21CFR Part 210, 211 & Part 4 as applied to combination products.
- Strong knowledge and understanding of ISO13485, ISO9001, and other international regulations.
- Experience in Quality Leadership in a Manufacturing environment for Drug Packaging of Combination Products
- Familiarity with document management databases, particularly MasterControl and SAP.
- Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
- Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).
- Excellent organizational skills with an ability to think proactively and prioritize work.
- Working knowledge of statistical data analysis
- Thorough understanding of validation activities and risk management principles and techniques
- Strong problem-solving and critical thinking skills
- Medical industry or highly regulated industry
Additional Requirements
- Work in a manufacturing environment, subject to heat and cold as well as loud noise.
- Work in an office environment. At times must sit for extended periods of time.
- Ability to effectively communicate and comprehend complex ideas and concepts.
- Use written and oral communication skills.
- Read and interpret data, information and documents.
- Must maintain the ability to work well with others in a variety of situations.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Ability to make independent and sound judgments.
- Observe and interpret situations, analyze and solve problems.
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
These jobs might be a good fit
