Seeking a highly experienced IT Business leader with strong skills deploying technologies that enable Regulatory, Clinical, Quality, Supply Chain, and CMC.
- Partner closely with Development leadership to create strategic business plans that align information technology solutions with organizational
goals, proactively anticipating gaps and overlaps.
- Manage the system selection process; helping end users to articulate business needs and requirements (developing Requests For Proposal (RFPs),
identifying and engaging vendors, overseeing contracting and negotiations, auditing vendors per our QA vendor selection SOPS, and managing
- Author, review and approve implementation artifacts (i.e. use cases, user requirements specifications, functional specifications, and standard
operating procedures for the maintenance and operation of software applications)
- Create shared vision of solutions and facilitate decision making relating to trade-offs both within and between different solution platforms and
the needs of stakeholders across functions.
- Ensure delivery of projects within determined schedule, scope, and budget constraints. * Build a regulated systems team that will scale with the
growth and direction of the organization
- Manage external vendors to ensure that best practices for the service, support, and ongoing compliance of critical, already-operational systems
- Ensure ongoing compliance through both formal and informal internal audits of projects, systems and supporting processes
- Travel to external vendors to oversee validation activities and perform vendor audits.
- Deep knowledge of GXP compliance as relates to IT governance, 21 CFR part 11, data integrity, and computer systems validation.
- Ability to incorporate compliance into scalable policies and procedures, harmonizing requirements across compliance domains as appropriate (Sarbanes
Oxley, MA 201, etc…)
- Experience leading change control processes, system development lifecycles, and a release management cycle for regulated systems.
- Ability to manage a portfolio of projects, activities and tasks simultaneously and autonomously.
- Experience with Validated ERP systems, eTMF and EDC systems, quality management systems, safety systems, eCTD submission systems and regulatory
- Strong communication and interpersonal skills
- Bachelor’s Degree (B.A./B.S.) or equivalent in Business Administration, Management Information Systems, Computer Science, or Project Management.
MBA or other relevant graduate degree preferred.
- A minimum of 10 years of Regulated system experience, preferably in life sciences, biopharma or related industry.
- Entrepreneurial, enjoys working in a fast-paced, small-company environment.
- High levels of organization, attention to detail, and accuracy
- Proactively identifies business needs and identifies process or technology solutions.
- Acts with urgency and passion. Enjoys supporting others.
- Strong written and verbal communication skills
- Fosters a collaborative environment; incorporates diverse perspectives in order to manage change effectively.