Sr. Quality Manager

Sr. Quality Manager

Requisition ID: 66480

Date: Oct 4, 2024

Location:

Tempe, Arizona, US

Department: Quality

Description:

Who We Are:

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 you will proactively lead, and drive the execution of the quality assurance strategy across the West, Arizona site by overseeing the elements of quality operations, quality control and quality system functions. The position is a key and active member of the Site Leadership Team in West, Arizona and interacts with the team to ensure business objectives are aligned and that the company is performing to operational objectives.

Essential Duties and Responsibilities:

Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact.

• Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company’s business planning / strategy development.

• 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 and components moulded, assembled, and packed by West, Arizona to meet and exceed all regulatory requirements, customer requirements and key performance indicators.

• The role will also have a dotted line reporting relationship to the Director, Operations, Arizona to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same.

• 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.

• Leads, develops, and executes on the local quality strategy for the West Arizona campus, 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. The role will 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 West, Arizona 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.

• 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 either pharmacy, chemistry, biology or equivalent.

• Significant experience (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:

• Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.

• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.

• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.

• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.

• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.

• Ethical Standards : Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.

• Self-motivated with a proactive attitude and the ability to work effectively.

. The ideal candidate will possess a profound strategic vision and robust leadership abilities to promote best practices in quality management and continuous improvement.

Travel Requirements:

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

Physical and Mental 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.

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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.