Title:  Sr Specialist, Quality Change Management

This is a hybrid role (3 days onsite) working out of our Exton office location. Candidates applying must currently reside 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:

The position is responsible for leading the coordination of Change Control activities and ensuring compliance with internal and external Change control requirements.  The role will serve as the subject matter expert and administrator for change control documentation for West’s proprietary packaging component and medical device businesses.

Essential Duties and Responsibilities:

• Manage overall global Change Control process from initiation through approval; leading change control review board activities (documentation, data, customer notifications and approvals, etc.).
• Collaborate with cross functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks.
• As lead Quality Systems point of contact, assist change owners to ensure adherence to corporate Quality System requirements
• Drives visibility and oversight to major changes across network to ensure applicability and consistency.
• Oversees assessment of change controls and assures change Impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e. combination products).
• Ensure change control information is accurately entered into the appropriate tracking database
• Provide mentoring and training to change owners on change control processes and tools.
• Lead global Change Management team meetings to continuously review, improve and evolve change management systems and processes.
• Monitor and communicate metrics and trend reports to management for the Change Control system as needed.
• Provide Guidance and mentoring to other members of the Change control team.
• Perform evaluation of change control processes and tools to drive continuous improvement activities.
• Escalate issues and concerns as necessary/appropriate to management.
• Create or update standard operating procedures and work instructions as necessary/assigned.
• Perform other duties as assigned.

Basic Qualifications: 

• Education: Bachelor or Master’s degree in science preferred or equivalent experience in related discipline
• Experience: Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry.

Preferred Knowledge, Skills and Abilities:

• Experience in regulated industry such as pharmaceutical and medical device.
• In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
• Experience with SAP systems
• Familiarity with document management databases, particularly MasterControl
• Solid communication skills with ability to communicate across all levels of the organizations and departments.

Travel Requirements:

• Minimal travel as required

Physical & Mental Requirements:

• Able to be aware of relevant SOPs as per Company policy as they relate to the position covered by this Job Description
• Work in an office environment.  At times must sit for extended periods of time.
• 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.
• Able to comply with the company’s Quality and Safety policy at all times

#LI-DJ1

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.