IT Help Wanted: [itroundtable] Senior IT Program Manager

Thursday, October 8, 2009

[itroundtable] Senior IT Program Manager - QA and Compliance

From: vijay kapadia [mailto:dru.kapadia@gmail.com]

I need your help trying to post some openings I am involved with in brooklyn. About 20 openings.

Please contact Tina C who's information is at the end of this posting.

Senior IT Program Manager – QA and Compliance

Position Description: Work with clients to understand and define business objectives, user requirements, and workflow requirements. The Senior IT Program Manager role will partner with the different business areas and project teams to gain a detailed understanding of global QA and Compliance processes and provide detailed guidance as to how to automate specific QA functions calling on their own IT application expertise to identify or verify requirements.

Position will potentially have considerable matrix management exposure thus the candidate must have experience in managing multiple stakeholders from across the enterprise.

Business Areas Involved:

· Audits (Regulatory Compliance, Clinical, etc.)

· Change Control – Clinical Quality Assurance, IT, Manufacturing, and Metrology

· Corrective Action Prevention Action (CAPA)

· Customer Complaints

· Deviations and Investigations

Responsibilities:

· Interact with multiple business groups, IT and related functions to determine requirements and workflows to satisfy an integrated Global Pharmaceutical QA/QC system.

· Assist in defining project objectives, schedules and priorities, articulate and effectively communicate project issues and status to project team members.

· Particular attention must be paid to the entire SDLC from requirements definition through specifications, implementation, and qualification.

· Coordinate the activities of requirements gathering and workflow definitions.

· Act as subject matter expert and technical resource to global QA and Compliance project team and the IT development and IT PMO staff in all phases of the development and implementation process.

· Participate on a team of internal subject matter experts, outside consultants, and system integrators.

· Participate in making technical decisions and recommendations to the business and IT.

· Translate business requirements into detailed technical requirements.

· Participate and coordinate with the validation team in generating test cases and the execution of test scripts.

Skills Required/Preferred:

· Technical expertise is required in global QA and Compliance process design, planning and applying IT solutions to the quality management business function in the pharmaceutical industry.

· Full technical knowledge of systems analysis

· Experience with Computer Systems Validation, Systems Development Lifecycle, cGMP requirements and Manufacturing is strongly desired.

· Technical familiarity with 21 CFR Part 11 and electronic signatures

· Ability to communicate with all levels - technical and management

· Ability to work and contribute in a team environment

· Good knowledge of global QA and Compliance systems, so as to facilitate timely decision-making

· Ability to identify and mitigate risks and issues

· Business system project management experience

· Ability to apply industry trends and metrics

· Exposure to international quality regulations and compliance issues that pertain to the pharmaceutical industry

· Familiar with audit/change control commercial software packages

· ReqPro and Quality Center tool experience a plus

Education: Bachelor degree in a Physical or Computer Science or chemistry or a related discipline

Industry Experience: 7-10 years of solid, diverse work experience in a large-scale deployment of QA and Compliance systems at a bio/pharmaceutical company including business process harmonization

Tina Costanzo

Senior Technical Recruiter

InSys Consulting Services, Inc.

201-621-4797 ext 32 (office)

201-306-5455 (cell)

201-621-4798 (fax)

tcostanzo@insysus.com

www.insysus.com