As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. 

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Job Title: IQC01J- Director IT, Quality Compliance

Brief Description: Lead Information Technology (IT) Global Quality Compliance (GQC) activities across the Company including setting strategic direction for the function, partnering with IT Operations to ensure minimal risk and effective mitigation strategies with internal and third party supplier systems, acting as a consultant to the client community, and managing IT quality compliance staff to ensure regulatory and business requirements are met.  

Specific job duties:

Responsible for ensuring that the Company’s quality systems and procedures meet US and international regulatory requirements – computer system validation (e.g., FDA/CFR, GxP, EMA, MHRA, EU GVP, HIPAA, ISO, NIST, etc.) as applicable for the business.  Set strategic direction for the IT Quality Compliance function(s)Partner with IT Operations to assess risk and develop mitigation strategies and develop validation processes to support system management according to applicable regulationsLead Quality initiatives to ensure data integrityPartner with GQC audit team to develop and implement risk-based audit strategies for third party supplier IT services and systemsEnsure quality compliance oversight of information systems implementation, testing, maintenance, and updates.  Manage IT quality compliance staffConduct and/or support internal and third-party vendor audits as related to IT activities including validation life cycle documentation within the Company.  Prepare audit report(s) and follow-up to ensure acceptable responses and CAPAs are received in follow-up to observations.  Host and support client and regulatory audits as related to IT activities within the Company.  Prepare audit responses and ensure CAPAs are implemented, completed, and effective.  Responsible for the coordination of IT related SOP and policy review and change on an enterprise-wide and business unit level.Support GQC department in enterprise-wide and business unit IT procedures, processes, training programs, audits, and CAPA plans.   Develop and implement educational programs on IT-related quality systems for Company. Supervise/lead system validation related activities for UBC systems (proprietary / COTS/other) such as the development of requirements, test script creation, and performance qualification (user acceptance). Ensure validation deliverables are appropriately captured including strategy and outcome.Act as a consultant to the client community relative to client system validation activities such as the development of requirements, test script creation, and performance qualification (user acceptance).Perform effective CAPA management within the UBC CAPA database.Conduct staff training, where appropriate.  Provide responsive advice, counsel, education and service to UBC concerning IT compliance issues and regulatory trends in the industry.Perform other quality compliance related activities as needed.  

Supervisory Responsibility: Position requires management of direct reports within the Quality Compliance department.

Desired Skills and Qualifications:

Bachelor’s degree in Computer Science or equivalent experience with a minimum of 5- 8 years’ experience within a regulated industry (e.g., pharma, medical device) or a Master’s degree in Computer Science with 5-8 years’ experience within a regulated industry.  Preferred requirements include a Bachelor’s or Master’s degree in Computer Science with at least 5-8 years’ experience within Quality Compliance within a regulated pharma and/or medical device industry.  Previous Managerial experience preferred.Substantial exposure to in-house and shared or outsourced systems, multiple hardware platforms and integrated information and communication systems.  Experience with financial, clinical, safety, and IVRs information systems.Experience with Quality Management Systems with focus on process improvement. In-depth working knowledge of Information Technology theory and principals and system validation life cycle.Experience with writing and reviewing management of Standard Operating Procedures (SOPs). Knowledge of applicable pharmaceutical/biotechnology regulatory requirements (i.e., ICH, GCP, FDA, MHRA, EU GVP, 21 CFR Part 11, HIPAA, ISO, NIST, etc) and their application to the IT area and Company business.  Preferred audit experience in conducting and hosting internal, vendor, client, and regulatory audits. Preferred experience with Corrective Action Preventive Action (CAPA) documentation including Root Cause Analysis, Action Plan Development, and CAPA Effectiveness Assessments.  Proficiency with Microsoft Office (i.e., Word, Excel, Outlook, Powerpoint).Proven skills in:Written and verbal communicationPlanning, analysis and creative problem solvingInterpersonal relationship buildingDemonstrated ability to:Always be honest with a high level of integrityCommunicate effectively and professionally across all levels of the organization, with clients/sponsors, and with regulatory auditorsManage multiple tasks and competing priorities in accordance with business needsRelate to all levels of the user communityBe a team player who motivates and educates other team membersWork independently under limited supervisionPlan, implement and support systems in a complex environmentComprehend complex, technical subjectsTranslate technical language to lay audiencesLink and apply complex technologies to business strategiesBe detailed orientedEnsure confidentiality and discretionTravel as necessary, expected 25-30% of time.

Benefits:

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally. 

Here are some of the exciting perks UBC offers:

Remote opportunitiesCompetitive salariesGrowth opportunities for promotion401K with company match*Tuition reimbursementFlexible work environmentDiscretionary PTO (Paid Time Off)  Paid HolidaysEmployee assistance programsMedical, Dental, and vision coverageHSA/FSATelemedicine (Virtual doctor appointments)Wellness programAdoption assistanceShort term disabilityLong term disabilityLife insuranceDiscount programs

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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