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 as an Associate Director, Global Quality Compliance!
Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Collaboration, Conscientiousness, Curiosity, Compassion, and Consultation. 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!
Brief Description:
This role is accountable for providing compliance oversight to the UBC Late Stage (i.e, Clinical studies, Pharmacovigilance, REMS) projects to ensure adherence to Good Clinical Practices (GCPs), UBC policies and procedures, and all applicable worldwide regulations and guideline (i.e., FDA, EU Directives, ICH, National regulations). Ensures that internal controls are implemented and are evaluated for compliance via different assessments methods across the concerned UBC projects to minimize regulatory, legal and business risk while effectively and efficiently supporting project and business goals. Supports audits and inspection for UBC Late Stage activities and provides Senior Management with oversight, analysis and risk management on quality matters. Reports to Senior Leader.
Specific Job Duties:
- Acts as a strong technical resource and primarily oversees project specific management aspects from a quality standpoint.
- May be asked to resolve GCP/PV/REMS issues based upon knowledge of applicable client requirements, SOPs, and regulations.
- Interfaces as a single point of contact for sponsors/clients, regulators, internal shareholders to provide guidance on Compliance issues related to Late Stage activities (GCP, Pharmacovigilance, applicable regulations).
- Proactively identifies and analyzes quality indicators and data for potential trends and risks and provides oversight to quality initiatives.
- Participates in process improvement initiatives across UBC and for sponsors/clients.
- Partners and participates in cross-functional activities across the organization to achieve company objectives. Prepares, conducts, and hosts Quality Compliance audits (i.e., GCP, PV, sponsor/client, investigator site, laboratory, REMS, third-party supplier, internal program/process). Prepares, reviews, and/or approves audit reports and responses. Ensures appropriate corrective and preventive actions are developed and implemented within required timeframes.
- Ensures UBC procedures, SOPs, guidelines and other standard materials required for the department are prepared, reviewed and that staff are trained.
- Ensures project specific documentation complies with contractual requirements and applicable international and industry standards. Ensures appropriate Late Stage document review
- Provides oversight to UBC CAPA Management Program for relevant projects.
- Monitors project specific quality related activities in terms of costs and utilization of operational resources.
- Ensures Quality Assurance resources are available to support internal and external audit programs, study management teams, and GxP-related training.
- Ensures the quality and integrity of data generated from UBC programs for submission to relevant regulatory agencies by overseeing the conduct of database, document, and investigator sites audits.
- Interprets global legislation, regulations and guidance’s for UBC to develop policies and standards, identify gaps and redundancies and coordinate and implement remediation in collaboration with UBC management and other groups such as Legal.
- Direct interface for UBC during regulatory inspections.
- Ensures set up and maintenance of a UBC inspection readiness program
- Provides inspection management support as appropriate.
- Provides training and mentorship to less experienced members of the Compliance staff.
- Evaluates client requests for proposals as requested.
- Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Requirements:
- Bachelor’s degree in a life science required; advanced degree in a scientific discipline preferred. Generally, has at least 10 years of pharmaceutical industry/drug development experience with at least 8 years of compliance and process management experience, and at least 5 years management experience of a global team; or equivalent combination of education and experience.
- Excellent knowledge of Good Clinical Practices (GCPs), ICH GCP Guidelines, Good Pharmacovigilance Practices and applicable regulations, and FDA Regulations including REMS.
- Extended experience with Regulatory authority inspections (e.g. FDA, EMA, other)
- Excellent interpersonal skills and the ability to communicate effectively across all levels of the organization.
- Good analytical and organizational skills.
- Effective team player and the ability to work across functional lines in a collaborative way.
- The ability to work autonomously with minimal supervision.
Supervisory Responsibilities:
May require Supervision of Quality Compliance staff supporting the UBC’s Late Stage Business Units.
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 opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount 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.
#LI-HB1
#LI-REMOTE
