Title:  Director of Quality

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, the Director of Quality, will lead and build a dynamic Medical Device QA team focused on standardizing and deploying best in class quality processes and communications across the Dublin campus.

As a member of the West Dublin Site Leadership Team (SLT), the Director of Quality will direct and oversee the Quality Assurance, Quality Engineering, Quality Systems and Quality Program teams while managing successful relationships with Design Quality. The role will lead the engagement and interaction with key internal customers specifically Design, Operations, Engineering and Continuous Improvement teams and will be first point of contact for key strategic external customers.

The position calls for transformational leadership on a growing campus recognized as a global center of excellence with significant growth projections. The role provides exemplary leadership, management, and direction to deliver on quality strategies, key performance indicators including, safety, quality, on-time delivery, and efficiency targets.  Leadership capacity to effectively engage with local and global leaders to deliver on global solutions and innovation is a key component of this role. The role will drive engagement across multiple sites in West to support common customer programs and medical device platform alignment.

Essential Duties and Responsibilities:

• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes.
• Directs and leads the Quality function for combination medicinal products, investigational medicinal products (IMP) and medical device products moulded, assembled, and packed by Tech Group Europe (t/a WEST) to meet and exceed all regulatory requirements, customer requirements and key performance indicators.
• Develop the organizational structure and talent to execute the West Dublin Quality imperatives and site strategy.
• In accordance with EU, US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations and registrations.
• This role will have responsibility as the Global Lead for Data Integrity across all Contract Manufacturing/ Medical Device.
• Ensure all products are developed, manufactured, tested, stored, and distributed in accordance with regulatory (e.g. US FDA, cGMP, ISO requirements), customer and West standards, guidelines and procedures. Directs Quality team to meet and exceed all key performance indicators.
• Leads, develops, and executes on the quality strategy for the West Dublin campus, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing/ Medical Device quality objectives.
• Ensures the promotion of awareness of applicable regulatory and Quality System requirements throughout the organization and champion the highest levels of patient first/ quality culture, customer service and engagement.
• Member of Customer/ West steering committees and business reviews which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• For Global Platform products manufactured in Dublin and Grand Rapids, this role will be first point of contact relating to Quality for our strategic customer across both geographical regions.
• Manage the customer satisfaction processes and lead improvements of overall customer satisfaction if discrepancies are identified.
• Directs West, Dublin QA in line with Sister Site agreement requirements for products manufactured at other West sites, e.g., contract manufacturing customers and products where West, Dublin holds the legal title of the manufactured products.
• 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 finished medical devices
• As the management representative, ensures the quality system is implemented and its integrity maintained
• 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
• Inspires innovation and quality excellence ensuring this culture is deeply engrained and sustained in the organization DNA
• Leads by example and sets the highest standards in employee engagement and communication.
• Is a champion for talent development (personal and team) ensuring commitment to local and global programs.

• Other duties as assigned based on business needs.

Basic Qualifications:

• Bachelor’s Degree in a technical discipline to include; Science, Quality or Engineering. Master’s degree a plus.
• Minimum of 10 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry.
• Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven
• Ideally be minimum ‘Greenbelt’ Lean Sigma trained with a proven track record of leading multiple value-add programs.
• Excellent computer skills, experience with MS Office, ERP systems, Statistical software etc.

Preferred Knowledge, Skills and Abilities:

• Able to lead and front multiple third-party Medical Device / Pharmaceutical audits
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.
• Ideally have minimum 5 years of experience in leadership role in a matrix organization. 
• Have in-depth / working knowledge of: ISO 13485; EU GMP inc. IMP requirements, US FDA CFR Part 820 & Part 4
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention.
• Able to lead and manage the performance of a multi-functional team
• Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs per company policy as they are related to the position covered by this Job Description.

Travel Requirements:

• Must be able to travel up to 10% of the time

Physical & Mental Requirements:

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet.  The noise level in the manufacturing work environment is moderate to loud.  Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.