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Dir, D&t, Global Lab Solutions

4 months ago

Exton, United States West Pharmaceutical Services Full time

Requisition ID: 65956- Date: Jun 10, 2024- Location: Exton, Pennsylvania, US- Department: Digtl & Transfrmtion- Description:
**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 Director, Digital & Transformation (D&T), Global Lab Solutions will be the principal solutions architect Laboratory Solutions supporting support of Global QA Laboratories. The director will lead a global team responsible for support, maintenance and implementation of Laboratory Solutions. They will also work closely with lab equipment support team, digital quality team and lab QA team to coordinate any global computer validation policy and work instructions. The director and global team will work with laboratory stakeholders to:

- develop a strategic roadmap for global laboratory solutions such as LIMS
- understand complex system requirements
- deploy features and enhancements based on requirements
- identify process gaps and implement solutions to close the gap
- increase efficiency and improve lab workflow process

**Essential Duties and Responsibilities**:

- Strategically collaborate with groups within D&T (infrastructure, cybersecurity, etc.) and across the organization (QA and Lab) to ensure global infrastructure support for lab computer systems
- Work with leadership team to plan for major key initiatives including lab automation, compliance and digitization.
- Ensure systems in the lab are compliant with cGXP and all data integrity standards to control costs, reduce risks and improve productivity.
- Ensure lab systems area have backup, archiving and electronic raw data can be restored on computer systems in the lab.
- Mentor and grow D&T lab support team members for server-based and integrated computer system support
- Drive continuous improvement process from technology-side using best industry practice
- Ensure the inventory list of laboratory computerized systems globally is maintained.
- Approve IQs, OQs, PQs, and validation protocols, as necessary.
- Review and approve documents such as laboratory investigations, work instructions, SOPs, etc, as required.
- Research, recommend, develop and/or implements new software/upgrades and systems to increase compliance and efficiency in all laboratories.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Assist with audits from both clients and regulatory agencies.
- Perform other duties as assigned.

**Basic Qualifications**:

- Bachelor’s degree or equivalent experience in Laboratory systems or a Scientific field.
- Minimum 10 years experience of managing Laboratory systems
- 5+ Years of experience with direct management experience

**Preferred Knowledge, Skills and Abilities**:

- Manage global team within D&T (matrix or direct)
- Extensive project management experience, especially in regulated industry
- Experience with implementing and managing laboratory computer systems
- Knowledge of Waters Empower, Waters NuGenesis SDMS, LabVantage LIMS a plus
- Knowledge of cGMP regulations, and validating cGMP computer systems
- Knowledge of the software development lifecycle
- Excellent communication skills
- Aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Basic understand of Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times List any safety requirements applicable to role within your country

**Travel Requirements**:

- Must be able to travel up to 10% of the time. Ability to travel globally

**Physical and Mental Requirements**:

- Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary c