Senior Manager, Design Quality

This is a hybrid role (3 days onsite) at our office location in Scottsdale, AZ. Candidates applying must be residing within a 50 mile commutable radius to the job 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 proactively develop, lead, and drive the execution of the quality assurance strategy. This role will be responsible for developing and implementing quality assurance plans ensuring compliance with regulations, overseeing interactions with regulatory agencies and building strong relationships with internal and external stakeholders.

Essential Duties and Responsibilities

• 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.
• 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.
• Oversee regulatory agency interaction related to compliance to local and regional guidelines/ regulations.
• Develop strong internal and external relationships with regulatory bodies and authorities.
• Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Responsible for ensuring QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.
• Responsible for developing a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis
• Coach, mentor and lead highly dynamic team members to help achieved the requirements of this position as well as the individual career goals of team members.
• 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.
• Play a role as a key contributor to documentation updating, including leading any updates.
• Participate in and drive compliance to global harmonization initiatives.
• Responsible for quality data trending e.g., CAPA, Deviations, Customer Complaints, Product Quality KPI's and Change Requests and driving quality improvements.
• Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.
• Acts as a mentor and coach to the business with respect to Quality and Regulatory knowledge.
• Fosters and encourages shared learning’s across West e.g., system and technology best practices and harmonization / standardization of West Procedures and practices.
• Perform additional duties at the request of the direct supervisor.

Education

• Bachelor's Degree Preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; required

Work Experience

• Minimum 10 years required and
• Previous leadership experience, preferably managing remote employees. preferred and
• Experience in regulated industry such as pharmaceutical and medical device. preferred and
• Project Management experience preferred

Preferred Knowledge, Skills and Abilities

• Strong knowledge and understand