Job Description

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 - D&T Validation & Testing is a key role responsible for defining, maintaining and optimizing the Quality Management System (QMS) framework in the context of all D&T Systems & Project execution. The role will lead a team focused on validation documentation, development and execution of protocols along with strategic planning for complaint computerized application operations in a regulated Pharmaceutical GMP environment. Key application areas include enterprise ERP (SAP), MES, Laboratory and Digital Applications. Collaborates with key stakeholders like Digital Quality Assurance & D&T leadership to ensure D&T Systems are compliant with regulatory requirements and internally approved processes like change control.
Essential Duties and Responsibilities:

• Manage and lead Computer Systems Validation team within D&T and accountable for ensuring computer system validation documentation for process & regulatory compliance including GxP, EU Annex 11 & 21 CFR Part 11.
• Responsible to implement risk-based computer system validation methodology with emphasis on risk identification, assessment and mitigation controls.
• Guide D&T team members on best practice regarding good documentation procedures related to cGMP and other regulatory requirements.
• Develop and maintain computer system validation plans, qualification test protocols, IQ/OQ protocols, traceability matrices, SOPs/SOIs, Controlled Forms and all other documents within the scope of System Development Life Cycle (SDLC).
• Participate & Lead in project teams to create, review, and manage documents as part of the delivery of the project overseeing the execution of validation plans & validation documents.
• Participate & lead system audits which impact cGMP operations.
• Ensure CSV Training material stays current and training of employees, temps and consultant to ensure compliance with our internal process and external regulations.
• Collaborate with Digital QA to ensure documentation requirements are effectively communicated, understood, and met, and that the governing procedures are followed.
• Coaches, trains, develops, motivates, and evaluates Validation team members to enable their capabilities and accomplish the department's priorities.
• Attracts, develops, engages, and retains talented individuals to achieve current and future business goals.
• Ensures team members have access to training, coaching, and mentoring to thrive in their respective roles and enhance professional development.

Education and Experience:

• Education: Requires Bachelor's degree in science related field, or Information Technology
• Experience: 8-12 years of experience in pharmaceutical validation of software applications, quality assurance, cGMP manufacturing.
• Preferred but not required: Agile & Scrum Certification, ITIL

Knowledge, Skills and Abilities:

• Deep expertise, understanding and knowledge of Computer Systems Validation in a regulated GMP environment for process and software.
• Strong experience in SAP ERP implementation, auditing & validation requirements along with working knowledge of digital applications, IoT etc.
• Understanding of business processes, controls frameworks, compliance and regulations for cGMP.
• Working knowledge of regulations for electronic systems validation and data integrity (eg 21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance)
• Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment.
• Working knowledge of different tool sets like HP ALM, JIRA, DevOps, MasterControl for validation purposes.
• Able to be aware of all relevant SOPs as per company policy relative to the position as applicable.
• Self-motivated, high work discipline, pragmatic approach while able to enforce mandate, excellent communication & people skills, strong service and support orientation.

Physical and Travel Requirements

• 10-15% travel, including global travel.
• Prefer to work 12:00 Noon - 9pm IST. Willingness to work outside of these hours as needed.

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 . 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.

Skills Required