IT Support Services Supv

3 months ago

Pune Maharashtra, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe

Job Overview:
Provide leadership, guidance, and management services for IT-led validation initiatives across Fortrea BUs. The Supervisor will liaise with Sr. Management to execute the Company’s overall Business Technology validation strategy by developing, formulating, and coordinating computer systems validation activities.

The position will manage resource allocations and provide oversight for projects that require interdisciplinary teams to assess and manage validation aspects within a highly regulated environment.

Summary of Responsibilities:

- Implementing and maintaining risk-based validation model & strategies
- Creative approach to resolving technical issues, and balancing business needs
- Plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments
- Self-motivator and starter to lead a teams on a unified validation strategy, while achieving department goals, objectives, and initiatives
- Program & Project Management experience - ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments
- Interacting with all levels within the organization
- Provide leadership and training to a small team of computer system validation professionals
- Demonstrates self-motivation to lead teams on a unified validation strategy, and while achieving department goals, objectives, and initiatives
- Taking direction from department management on goals, objectives, and initiatives

Qualifications (Minimum Required):

- 6+ years experience in execution of projects, 4+ years partnering/guiding clients at the project level
- 3+ years leading computer systems validation projects
- 3+ years managing a small group of technical professionals
- Experience with a validation methodology (SLC), and implementation in an IT organization
- Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GxPs)
- Ability to interact with all levels within in the organization
- Ability to interact and collaborate with external auditors and regulatory inspectors
- Exceptional verbal, written, presentation, interpersonal skills, and ability to command respect of others
- Strong interpersonal skills and ability to command respect of others
- Highly self-motivated and directed professional, with keep attention to detail
- Team Player

Experience (Minimum Required):

- Minimum 6+ years’ experience in execution of projects and partnering/guiding clients at the project level
- 3+ years’ experience working in the GxP regulated industry and with a computer validation methodology
- 3+ years in a supervisory experience and leading validation projects

Preferred Qualifications Include:

- 6+ years experience in an FDA/MHRA/OECD (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)
- Bachelor’s Degree or higher preferred (ex. science based, operations research, technology, etc.)
- Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.)
- Experience with major GxP regulations such as FDA 21 CFR Part 11, EMA Annex 11, MHRA and EU GDPR

Physical Demands / Work Environment:

- Office based at a Fortrea site or remote work as authorized by company policy
- Minimal travel to support client audits, site inspections and vendor assessments
- Desk and computer system environment

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, v

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