Digital Data Systems and Applications Sr. Manager, Engineering

Novartis • East Hanover, NJ

112d • $114,900 - $211,900

About The Position

This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. Novartis is a world-leading healthcare company that provides solutions to address the evolving needs of patients worldwide. Our TRD Cell & Gene Therapies Engineering department is looking for an experienced Digital Data IT/OT Systems and Applications Sr. Manager. The ideal candidate will have a proven track record in managing and overseeing digital data systems and computer system validation activities for lab-based instrumentation and equipment relevant to the field of Cell & Gene Therapies. The candidate will be responsible for DQP & GMP compliance relating to, but not limited to, workstation applications, network and server compliance and will assume role as “Super User” for data systems such as SAP S4 HANA.

Requirements

• Bachelor's degree in Engineering IT or Computer Systems discipline or Engineering Data Systems related field with significant prior experience (5+ years) or equivalent preferred.
• 5+ years of cGMP Pharmaceutical IT/OT system and applications, or equivalent industry experience required.
• Good working knowledge of cGMPs and DQPs with a solid understanding of the concepts of GMP, GLP, FDA and Health Authority Guidelines.
• Project management experience, may include leading teams or projects with demonstrated leadership skills in team building and accomplishing complex projects.
• Must demonstrate excellent communication and team building skills when interacting with personnel at all levels.

Nice To Haves

• Interpersonal and operational Savvy, collaborating across boundaries, managing people challenges and stakeholder engagement.
• Continuous Learning (Knowledge Development)

Responsibilities

• Act as the Senior local IT/OT and business system applications manager, builds cross-functional relationships between the business and various, global operational groups to ensure success of Digital Data IT projects.
• Partner with the Lean Digital Core team on IT/OT Projects in the pipeline, (e.g. - SAP S4, MES, CMX, KNEAT, GLIMS), and assume Super User responsibilities for site digital data systems.
• Owns / ensures IT/OT systems and procedures (DQP & GMP) follow established regulatory standards, local and global policies and procedures and acts a lead facing internal and external inspectors/auditors during regulatory inspections.
• Owns OT related compliance actions including change controls, deviations and quality events.
• Identify root causes, evaluate, and recommend optimal solutions to prevent future issues.
• Oversee the development, implementation, and use of technology throughout the CGT organization.
• Coordinate IT/OT projects, from managing system updates to implementing new technologies.
• Develop and execute an IT/OT strategy that aligns with the organization's digital data goals and objectives.

Benefits

• The pay range for this position at commencement of employment is expected to be between $114,900yr and $211,900/yr.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards.
• Full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree