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Manager, Computer System Validation

Contribute to outstanding innovation + Make braver choices
 
Manager, Computer System Validation
Location: Parsippany
 
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives.

Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our ‘people first’ philosophy.

Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
 
Summary:
 
The Manager, Computerized Systems Validation is responsible for providing oversight and assurance that computer systems validation and IT compliance management lifecycle activities are in adherence with regulatory (GxP) and corporate requirements for the Ferring U.S.

Technical Operations site (FPG).

This role will be expected to provide key support for the computerized system project teams in the planning, development, review and approval of system validation and infrastructure qualification documentation and protocols.
 
Responsibilities:
 


* Partner with Global/Site Quality Assurance teams and the end user community to continuously improve, educate and reinforce data integrity and data management concepts and best practices throughout the computerized systems lifecycle. 


* Partner with multi-functional teams on system implementations, problem resolution, and process improvement projects.

Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program.


* Perform gap analysis of validation documentation, systems and practices.

Communicate identified gaps including recommending and implementing corrective actions and improvements.

Perform periodic system reviews with business and system owners.


* Report key metrics and generate or review/update computer system related policies, procedures, templates, forms, etc


* Provide active support during regulatory agency and third-party inspections


* Research new technologies, understand existing processes, and reference recognized standards and frameworks


* Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned


* Identify opportunities for continuous improvement


*

Requirements:
 


* College degree (life sciences degree preferred) or equivalent experience;


* Minimum 7 years of experience providing quality oversight for the development, testing, implementation and validation of computerized systems used by pharmaceutical companies


* In-depth knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity concepts;


* Experience in the Biotech/Pharmaceutical Industry or sim...




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