IT Manager, Records Management (G&A)
The position will act as the technical owner and leader for systems supporting Avanir’s G&A records management functions, supporting Quality, Compliance, Legal, and Intellectual Property business functions. Acting as an internal “consultant”, the position is expected to partner closely with functional leaders within the Quality, Compliance, Legal, and Intellectual Property business functions to identify opportunities to leverage and evolve our technologies in support compliance with regulatory requirements, Avanir standards, and culture focused on records management. The position will also be expected to provide direct supervision of contractors & third-party service providers as well as indirect supervision within IT and cross functional organizations. This position will also be expected to be an enterprise thinker and collaborator, working with peers across the G&A IT teams at affiliate Otsuka Pharmaceutical companies to share knowledge and develop innovative solutions that can have broader reach and impact.
Successful candidates are expected to have expertise, knowledge and hands-on experience guiding and supporting records management business processes and IT capabilities and systems, for the Quality, Compliance, Legal, and Intellectual Property divisions of companies within the pharmaceutical, biotech or medical devices industries. In addition, the candidate will have demonstrated experience working with cross-functional services groups, including IT, Quality Assurance, Project Management, Legal and Compliance, to ensure successful business alignment, application integration, solution delivery, technology architecture, GxP compliance, system maintenance & operational support, and IT security that meet or exceed the quality standards and compliance requirements expected within the pharmaceutical industry.
Essential Job Functions:
- Act as a technical lead and participate in projects/programs to drive the delivery of technology solutions related to records management for Quality, Compliance, Legal, and Intellectual Property business functions. Contribute to user requirements specification, design specification, system and business configuration, system build, validation plan and report, test scripts development and execution, technical manuals, user training, system release to production and transition to operation.
- Demonstrate a strong understanding of records management process and best practices. Provide thought leadership and guidance to effectively guide and support the execution of records management for the company.
- Demonstrate a strong, consultative, and collaborative style to partnering within Avanir and across Otsuka affiliate IT teams to achieve Avanir business goals and solve identified business issues.
- Facilitate the evaluation and selection of technology vendors in alignment with IT standards. Educate and advise team members on technical options, including feasibility (benefits, risks, pros and cons), approach, alignment to applicable standards and support expectations (cost structure, resource requirements).
- Develop and manage software lifecycle management strategies and roadmaps that align with defined business strategies and support achievement of G&A IT goals.
- Support risk and impact analysis assessments of new systems to business processes/operations, and changes to existing systems according to Avanir policies & procedures, and regulatory compliance requirements.
- Accountable for the overall health (maintenance, operation, training, access, usage, change, quality, and compliance) of Quality, Compliance, Legal, and Intellectual Property records management processes and systems.
- Work with internal & external groups to manage the Avanir records management process and systems maintenance and operational support. Coordinate effort, and engage appropriate stakeholders, users and vendor staff to manage and maintain records according to policies and procedures. Coordinate effort, and engage appropriate stakeholders, users and vendor staff to manage system maintenance needs, product releases, service requests, incidents, problems, and change controls.
- Establish strong working relationships with IT systems user communities, other business functions, and across Otsuka affiliate G&A IT teams to ensure the appropriate adoption, effective usage and adequate control or Avanir records and of IT systems, and the adherence to industry and government regulations.
- Provide input to Service Level Agreement between Avanir and Vendor, and between Avanir IT and Business Functions. Report performance metric and identify opportunities for improvement.
- Be the point of contact within Avanir and between Avanir and Vendor for the reporting and escalation of technical issues that require Vendor support.
- Ability to quickly learn, adapt, and master new IT systems that support the G&A business operations.
- Partner with Avanir/Otsuka functional team members and within Avanir IT to ensure effective implementation, compliance and support for Avanir IT systems, including information security, integration with other IT systems, data integrity, system governance and technology architecture.
- Communicate effectively with supervisors, peers, project managers, and stakeholders.
- Must have strong work ethic, trust, integrity and accountability.
- Other projects or duties as assigned.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
- Bachelor’s degree in Information Technology, Engineering or related scientific, technical or business field.
- 8+ years of relevant work experience in an Information Technology role, including 2-3+ years in pharmaceutical/biotech/medical devices industry supporting Records Management systems (DocuSign, SharePoint Online, Veeva QualityDocs, etc – preferred).
- Strong interpersonal, analytical and problem-solving skills. Excellent written and verbal communication skills.
- Exceptional customer service focus and perspective. Must be well organized, flexible and responsive with the ability to handle multiple tasks simultaneously.
- Practical IT Service Management experience and knowledge of industry frameworks (i.e., ITIL, CMMI, etc.) including services provided by Vendors is preferred
- Experience with System Development Life Cycle (SDLC) and GxP Computerized System Validation (CSV), including a thorough understanding of risk-based validation and change management is required.
- Experience supporting enterprise level G&A IT systems (i.e., Electronic Document Management Systems, Legal Hold Systems, Electronic Signature Systems, Privacy Management Systems, etc.) and other innovative technologies or platforms is preferred.
- Experience with Platform as a Service (PaaS) and Software as a Service (SaaS) is preferred.
- Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.).
- Core competencies for this role include:
- Adapt to Change – demonstrate Organizational Awareness, Self-Awareness, Proactivity and Learning Agility
- Work Collaboratively – embody Teamwork, influence without authority, and demonstrate Technical Expertise
- Apply Judgment – effectively leverage Prioritization, Problem Solving and Decision-Making skills to achieve superior results
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.
As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.
Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.