Manager, Information Technology

POSITION SUMMARY: Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan (Ash Stevens, LLC, hereafter referred to as PPS-Riverview), is seeking a qualified IT Manager to join our IT team. The IT Manager is will ensure efficient operation of the IT department in alignment with Piramals’ IT objectives while meeting acceptable service levels for the user community

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
Identify and protect the original technical information as part of the company property.

Key responsibilities.

• As a Strategic Business Partner, proactively recommend IT Solutions / products to Quality Functional leaders by aligning to PPS vision and industry trends by bringing outside-in perspective
• Acts as a change agent to create sustainable technology capabilities across PPS Quality.
• Acts as a thought leader on emerging digital business models and technologies.
• Lead IT strategic, operational planning and implementation to achieve business, prioritizing IT initiatives, and coordinating the evaluation, deployment, and management of current and future IT systems.
• Knowledge about Electronic Content Management systems such as Empower, Agilent Openlab and Lab Analytical systems.
• Review performance of IT systems to determine operating costs, manage IT Budgets and productivity levels.
• Define and implement IT policies, procedures, and best practices, working closely with management to help maintain FDA compliance on all IT infrastructure and applications as needed.
• Leading and deploying significant IT Quality related product (e.g. LIMS, SAP, Paperless labs, EDMS) in a medium or large global pharma organizations.
• Plan and coordinate IT-related activities provide direction and support for daily and mission-critical operations of the IT department.
• Coordinate and facilitate consultation with relevant Site and IT stakeholders to define business and systems requirements for new technology implementations
• Responsible for the prioritization of projects assigned to the Application Development team (either internal or with external partners)
• As a Strategic Business Partner, proactively recommend IT Solutions to Site leadership team by aligning to Site vision and industry trends by bringing outside-in perspective
• Acts as a change agent to create sustainable technology capabilities at Site
• Sound understanding of portfolio, program and project management and a track record of delivering and enabling complex change programs within manufacturing Site
• Collaborate with Piramal Quality e-Compliance (QeC) team and ensure Quality Compliance as per defined SOPs and guidelines in accordance with 21 CFR Part 11, GAMP guidelines
Collaborate with Information Security team and ensure adherence to Information Security guidelines and processes

KEY INTERACTIONS.

• Effectively communicates with all levels of the organization to ensure project success and user needs are identified and met. Makes presentations to a wide variety of audiences within the organization.
• Site Leadership, Function Heads and Group IT Team (SAP, Corporate Systems including Quality)
Vendors / Partners (Tier 1,2, Startup ecosystem etc.)

EDUCATION/EXPERIENCE.

• Bachelor of Engineering / Related degree in Computer Applications with preferably a management degree.
• At least 10-12 years’ experience out of which at least 6-8 year
• Experience of technologies such as SAP, BI, Regulatory & Pharma Quality applications
• Proficient in Pharma CSV process
• Awareness of emerging Digital trends and their application within Quality context.
Proven working experience as an IT Manager

job competencies.

• Good knowledge of Quality related applications & software validation
• Excellent written and oral communication and interpersonal skills.
• Self-motivated, strong attention to detail and time management is critical for success.
• Follow FDA, EPA, OSHA, GMP and 21 CFR Part 11 regulations.
• Exceptional customer service orientation and working in a team-oriented, collaborative environment.
Willing to work off-shift times, as necessary, to complete projects.

job conditions.

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

• Physical Demands :
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of standing and walking can be expected in this position.
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.
• Work Environment :
  • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
  • Potential limited exposure to hazardous chemicals.
  Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
  

equal employment opportunity.

Piramal Pharma Solutions is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.