HireDiversity

Fort Washington, PA, US

MANAGER, IT RISK ASSURANCE - CD-6502130104

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a IT Risk Assurance Manager, SDLC/GXP/Training, CD located in Fort Washington, PA.

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.

McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J family of companies or beyond, or whether this is your entry to the J&J family of companies, we invite you to join us….

Creating the future of McNeil.

The IT Risk Assurance Manager, SDLC/GXP/Training is responsible for ensuring that IT personnel and processes for assigned portfolio in North America adhere to SDLC, GXP and training requirements throughout the system life cycle and in ongoing operational IT processes. The position reports to the IT Risk Assurance Director, SDLC, GXP & Training. In order to accomplish these objectives, the Manager will act as Subject Matter Expert, manage IT personnel and work with applicable stakeholders inside and outside Johnson & Johnson.

This position is essential for Consumer to achieve and demonstrate its compliance to regulatory requirements and to support Consumer Operating Companies' ability to pass FDA and Health Authority inspections.

Manage CSV remediation effort for IT applications identified in consent decree work plan. Partner with Quality Assurance and IT stakeholders to institutionalize new processes, governance, procedures, tools and metrics as an outcome of new quality standards for validation, electronic records, electronic signatures, and change control. Act as trainer and coach for new CSV processes to IT and business associates.

Oversee the SDLC/GXP/Training adherence initiatives for I/T Consumer North America for assigned portfolio of projects or processes. Align with IT Risk Assurance personnel in North America and other regions. Act as subject matter expert and coordinate the work of other to execute the following adherence activities:

Coach IT project and support teams on SDLC (including CSV, 21 CRF Part 11) to ensure IT applications are developed and maintained according to quality & compliance principles. Create, review and/or approve SDLC documentation; hire & manage SDLC/CSV contractors in projects as appropriate.

Address and assist teams in addressing unusual and non-recurring problems by devising new compliance approaches, strategies and processes. Proactively resolve conflicts between compliance requirements and project/business constraints.

Ensure IT audit readiness for internal QA audits and inspections by external health authorities, assist IT teams in developing responses to audit observations, conduct inspection readiness assessments, maintain close partnerships with J&J QA organizations.

Initiate and manage improvement projects for the Consumer to drive SDLC adherence and harmonization across the enterprise, in close association with the other sectors and J&J IT Shared Services.

Be a member of SDLC and GxP related governance boards, strategic initiatives, or teams working across sectors and/or with J&J IT Shared Services to develop policies and procedures, or on cross-sector initiatives.

As a member of the Consumer IT Risk Assurance Leadership Team, contribute to the strategic direction, strategic objectives and business plan for the IT Risk Assurance function in Consumer; Develop IT talent for the organization. Report metrics and dashboards, and make periodic reports and presentations to Leadership Teams and Compliance Committees on status of compliance activities in scope

Qualifications


A Bachelor's Degree is required, a Master's Degree is preferred. Candidates must have a minimum of 8 years of relevant working experience and 4 years leading/managing teams in the pharmaceutical and/or medical device industries. A minimum of 3 years of experience and demonstrated leadership in SDLC, CSV or related compliance function (Quality, I/T) is required. Experience leading regional or cross-company teams and working with virtual teams is required. Thorough knowledge of SDLC methodology, 21 CFR Part 11, GxP and CSV frameworks and best practice models like GAMP is required. Thorough knowledge of regulatory inspection practices is required. Working knowledge of Information Security is preferred. Ability to apply risk-based thinking to complex compliance problems and devise lean, effective solutions that balance the needs of both the business and compliance priorities is required. An understanding of GMP business processes is required. Excellent teamwork, communication, networking, and influencing skills, including the ability to manage projects across management levels is required as is the ability to lead , collaborate, challenge and influence peers, subordinates and management to drive compliance. The ability to successfully manage multiple critical issues simultaneously and interact with senior leadership teams is required. Excellent verbal and written communication skills, including formal presentation skills are required. This position will be based in Fort Washington, PA and may require up to 10% travel.

Assignment duration of the IT Risk Assurance Manager, SDLC/GXP/Training - CD to last through December 2014.

All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)