Quality Manager - Contract Manufacturing

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

The Manager, QA Phoenix serves as the management representative as defined by ISO 13485:2016 section 5.5.2. Interaction with both internal and external customers, as well as quality and regulatory agencies, to achieve department and company goals. Assure compliance of the plant processes and products to established industry standards, specifications, and procedures, ensure quality system is implemented and its integrity maintained.

Essential Duties and Responsibilities:

Although much of the work performed in this role impacts the local team and/or new product development teams, 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.

• Establish and execute Quality strategic plans and policies for Scottsdale Operations site and provide input into the QE objectives for the Scottsdale Development Center.
• Oversee and develop the corporate Facility Audit Program to help assure compliance to internal/external requirements, including customer requirements and strategic initiatives.
• Conduct training and re-certification as appropriate for quality and other personnel in relation to improvements of the quality system.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Complaint, Doc Control, Lot Release).
• Lead Regulatory/customer audits.
• Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a 'culture of quality'.
• Assure that the Quality System is compliant with applicable Regulatory and Industry standards, specific to Medical Devices.
• Ensures timely resolution to customer inquiries (audit findings and complaints)
• Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.
• Conduct Management Reviews as required by procedure.
• Serve as Management Representative for the SCO site.
• Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
• Provide leadership and guidance to Quality Operations team, Quality Engineers (both SDC & SOC)
• Manage Quality Staff at site to assure knowledge and execution of site Quality System
• Assure proper use of change management associated with validated processes.
• Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness.
• Drive continuous quality improvement projects and global harmonization initiatives.
• Maintain clear communication paths with stakeholders.
• Performs other duties as assigned based on business needs.

Basic Qualifications: 

• Bachelor's Degree in Engineering or Science preferred or a combination of education and work experience that results in required level of knowledge, skills and abilities.
• 10+ years of work-related experience required. 2-3 Years of supervisory experience required.

• Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc).

Preferred Knowledge, Skills and Abilities:

• Master's degree preferred with an emphasis in Engineering, Science, or Business. 
• Superior organizational and leadership skills with ability to help team grow and thrive.
• Experience with Customer interface and meeting customer expectations.
• Demonstrate team building and problem-solving skills.
• Ability to effectively prioritize and escalate issues.
• Working familiarity with Project Management Tools and Quality Risk Management.
• Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals and/or Plastics manufacturing.
• Demonstrated people skills specific to team building, problem solving and conflict resolution.
• Excellent presentation, writing, verbal, computer, interpersonal and communication skills.
• Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
• Manages competing demands, makes timely and sound decisions, even under conditions of risk.
• Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding.
• Effectively influences actions and opinions of others.
• Must possess knowledge of regulatory and governmental guidelines and requirements (FDA, ISO, cGMP, GLP, OSHA).
• Ability to perform effectively and efficiently in a fast-paced environment.
• Direct/Indirect Reports: Approximately 50+ employees.

Travel Requirements:

• Travel to other West sites as necessary/conduct external audits (<25%).

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.

#LI - KR1

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.