Sr. Manager, Global IT Compliance

Location
Emeryville, CA, United States
Posted
Jul 13, 2021
Ref
1118
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION:

This position’s primary responsibility will play a key role in overseeing all global IT Compliance related topics within the Digital and Information Technology (DIT) Division at Santen, reporting directly to the Head of DIT North America Region & Global IT Compliance.

This includes the review and improvement of the global IT Compliance framework to be in line with the strictest compliance regulations so that Santen will not face any major deficiencies in IT Compliance audits. The job holder will serve as validation leader during global IT system implementations and ensure IT compliance during and after the implementation process. This individual will also be a DIT partner for the Santen Quality Assurance (QA) departments around the globe and especially serve as the dedicated DIT Business Partner for the QA department in North America.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Review and improve the global IT Compliance framework at Santen to adhere to the strictest global compliance regulations (usually regulations coming from the FDA).
  • Contribute defining and implementing the future strategy around IT Compliance at Santen.
  • Develop the plan for ongoing IT Compliance operations and how to ensure global IT resources have the proper knowledge to adhere to compliance regulations.
  • Take full responsibility of IT system compliance during system implementations by taking over the validation leader role in global DIT initiatives.
  • Collaborate with IT Compliance resources in other regions and provide guidance and training about how to apply a global IT Compliance framework.
  • Develop a globally reusable IT Compliance training and serve as a direct trainer for global compliance resources. Furthermore, establish a train-the-trainer approach moving forward, secure relevant global resources and make sure the IT Compliance framework is sufficiently trained within the global DIT Division.
  • Serve as IT Compliance contact person for all global QA departments.
  • Specifically serve as the dedicated IT Business Partner for the QA department in North America.
  • Ensure that Santen systems running in North America are compliant with GxP regulations.
  • Serve as the dedicated IT contact person in case of audits (mock audits or official FDA audits) to answer all compliance related questions and take responsibility for the answers.
  • Manage external compliance vendors. Ensure they comply with Santen requirements about budget, deliverables, etc.

QUALIFICATIONS:

Core Competencies, Education, and Experience:
  • BS/BA degree or equivalent experience in Information Systems, Computer Science, Software Engineering, or related field.
  • 8+ years of progressive experience in the pharmaceutical industry and especially with pharma IT compliance regulations within a global environment
  • Expert knowledge in IT compliance and relevant regulations like GxP (incl. GMP), 21 CFR Part 11, etc.
  • Experience in IT system implementations in at least a consultant role and deep understanding about compliance processes during system implementation.
  • Knowledge and experience in defining/improving Pharma IT compliance frameworks.
  • Experience in managing external compliance vendors.
  • Strong collaboration/communication experiences in diverse/cross-cultural organizations.
  • Knowledge and experience in operating a regulated IT system environment.
  • Proven leadership skills in an ambiguous or changing environment.
  • Strong in logical thinking, time management, decision-making, and problem solving as able to manage multiple programs and priorities simultaneously.
  • Excellent interpersonal, organizational, planning, presentation, documentation, facilitation, and communication skills and be capable to clearly articulate the viewpoint.