Share this Job
Apply now »

Title:  Director, Glass Systems Quality and Regulatory

Requisition ID:  47452
Date:  Jul 31, 2022
Location: 

Exton, Pennsylvania, US

Department:  Quality
Description: 

 

 

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 work collaboratively work with the head of Glass System Product Management, Glass Systems Technical Applications and the head of Glass System Development to provide input and oversight to the development and testing of West glass systems. This includes building out & executing quality and regulatory systems  to support the  product line. In partnership with the Sr. Director, Product Management, Glass System responsible for optimizing and managing aspects of the Quality Management System (QMS) and Regulatory Affairs function related to the glass systems division of West including quality engagement with all supplier/partners. Ensure compliance to regulatory requirements in support of the manufacturing, testing, disposition, and distribution of West products. Provide interpretation and direction to Operations and R&D related to cGMP and related regulations as they apply to West products and processes. Active engagement of data and process digitalization  to effectively support customer quality and regulatory needs in line with glass systems strategy.

 

Essential Duties and Responsibilities:

  • Assisting with the execution of industry leading quality and regulatory compliance for developed components and systems. Anticipate customer needs based on market and regulatory direction and globally develop strategies that leverage innovative responses that can differentiate West in the market.
  • Understand and interpret complex pharmaceutical, medical device and combination product industry issues, trends and implications to Development, Technical, Quality and Regulatory disciplines. This includes aspects of QbD and design control execution, support for P.A.T and identification of risk-based sampling plans.
  • Assure appropriate processes and procedures are in place to manage the lifecycle of the developed products and change management of associated documentation/data. Assure archival and traceability needs are met. Actively support digitalization of this information, where appropriate.
  • Serve as Quality and Regulatory management representative for systems unit.
  • Manage and provide direction to Regulatory Affairs function and personnel on applicable regulatory filings required for West product and provide support to customers when needed.
  • Advice on strategic and conceptual direction that can be applied to the development of new systems or improvement to current systems.
  • Interface with peers and counterparts of strategic customers for improvement of relationship and product performance requirements.
  • Manage department budget
  • Work in a complex diverse and international environment to obtain solutions based on a solid background of the pharmaceutical and medical device industries and knowledge of combination products.
  • Actively stay aware of all updates to guidance and regulation that may impact West customers and help to interpret opportunity for West.
  • Other duties as assigned.

 

Basic Qualifications: 

  • Bachelor’s degree
  • 8-10 years’ experience
  • Expertise in establishing and maintaining effective regulatory and quality systems in a diverse environment.
  • Thorough understanding and applicability of cGMP, 21CFR 210, 211, 820; ISO 9000, ISO 13485 and all other related standards and regulations applicable to injectable combination products, constituent devices and components.
  • Proven track record in successful managing and leading professional staff.
  • Understanding of scientific methods, engineering practices and ability to interpret and communicate data to management, customers and regulatory agencies as required.

 

Preferred Knowledge, Skills and Abilities:

  • Successful experience in managing in a global environment
  • Ability to speak in public, conduct technical and regulatory writing and engage with Sr leadership
  • Credibility in the market is a plus
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.

Travel Requirements:

  • Must be able to travel 20% to 60% domestically and internationally involving multiple time zone changes in a short period of time.  Limited to zero advance notice.

 

Physical & Mental Requirements:

  • List any physical requirements
  • List any mental requirements

 

Competencies/Authorities

  • Non-US only where required for certain levels

 

 

 

 

 

 

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.

Apply now »