Quality Systems Senior Manager

ONSITE POSITION IN SCOTTSDALE, AZ. Candidate applying must be within a 50 mile radius to the location.

 

Who We Are:-

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:

In this role, you will manage the Quality Management Systems group. As part of this role responsibilities are QMS activities that includes the management of CAPAs, NCR’s, Issue Reviews, Deviations, and other QMS elements as applicable in addition to the document control organization. This role may lead and be responsible for Site Management Review, customer projects as needed, quality events documentation, quality audits (customer, internal and external), and customer notification of changes. An additional key element for this position is to work with a continuous improvement mindset to improve the Quality Systems, assure compliance with our policies, procedures and regulations and assure that we are performing value added activities that will improve the overall customer satisfaction. Developing the infrastructure for the Quality Systems function, aligning with the strategic plan for Quality, Scottsdale operations center and for the Global West business. Assure that the Quality System is current and meeting the needs of the customer base, applicable Regulatory bodies and Standards. 

 

Essential Duties and Responsibilities:

•  Assist in the execution Quality strategic plans and policies for Scottsdale site.
• Prepares the site for internal/external/corporate audits.
• Lead/Execute the internal auditing process.
• May lead and support the execution of external (customer and regulatory bodies)/corporate audits.
• Conduct training and re-certification as appropriate for quality and other personnel in relation to improvements of the quality system
• Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.
• Creates Goals and Objectives for QMS organization and development plans for the team members
• Address human resources cases as needed.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Issue Reviews, Deviations, Doc Control, Lot Release, auditing process, Management review process, etc.).
• Assure that the Quality System is compliant with applicable Regulatory and Industry standards.
• Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.
• Prepares Quality Systems Management Review (QSMR) and follow-up on action items open during QSMR.
• May lead External Standards process to ensure applicable standards are assessed for the new applicable changes.  
• 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.
• Other duties may be assigned as needed.

 

Basic Qualifications: 

• Bachelor’s degree or equivalent experience in Engineering or Science preferred

• More than 10 years of work-related experience required with 3-5 Years of Supervisory experience.
• Must possess knowledge of regulatory and governmental guidelines and requirements (FDA: 21 CFR Part 820, ISO 13485:2016, cGMP, GLP, EU-MDR, )

 

Preferred Knowledge, Skills and Abilities:

• Master’s degree preferred with an emphasis in Engineering, Science, or Business. 
• Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
• ASQ - CQA/CQE Certification is preferred.
• Lead Auditor certification is preferred.
• EU-MDR certification is preferred.
• Demo