UBC · 8 hours ago
Sr. Director, Global Quality Compliance - Biotech/Pharma
United States
Full-time
Remote
Director/Executive
15+ years expUBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow. The Sr. Director, Global Quality Compliance will be responsible for developing and implementing global strategy and policy relative to quality management systems to ensure compliance and provide quality services for sponsors.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Defines quality objectives and strategies to meet customer requirements and UBC goals and objectives
Facilitates groups or teams through the problem-solving and creative-thinking processes leading to the development and implementation of new approaches, systems, structures, and methods to ensure overall quality processes and services across the organization
Generates creative new solutions and approaches to customer issues and organizational quality processes
Participates in cross-functional activities to achieve organizational objectives
Implements quality related solutions to organizational problems and develops organizational or service delivery systems in a way that factors in or encompasses the interactions of all of the systems and organizational entities involved
Leads and manages processes that provide oversight and guidance to monitor and assure compliance with quality management system requirements and all applicable good practice regulations, i.e. clinical (GCP); Pharmacovigilance (GPvP); Laboratory (GLP), Risk Evaluation Mitigation Strategies, application validation relating to UBC regulated activities
Effectively manage the development, implementation, approval and maintenance of quality assurance systems and processes
Ensures UBC procedures, SOPs, guidelines and other standard materials required for departmental function are prepared, reviewed and that staff are trained
Directs and control the quality related activities across UBC through functional line management
Develops and maintains the annual operating and capital budgets for the department
Responsible for monitoring departmental activities and costs as related to the overall utilization of resources required to meet operational requirements
Participates in due diligence and integration activities of newly acquired organizations
Ensure that annual audit risk based plans are developed and executed
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
With support of the UBC Legal Department, 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 (FDA, EMA, MHRA/Health Canada) as well as primary interface with clients and Marketing Authorization Holder (MAH) auditors during pre - assessment /ongoing qualification audits
Verify that appropriate follow-up and corrective action is taken as a result of audit observations and investigations and that corrective actions are reviewed and analyzed to identify process improvement initiatives Serves as the Quality representative for Governance Committees for larger client relationships/partnerships
Review and approve quality agreements between UBC and clients
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
Qualification
Required
Bachelor's degree in a life science required
Generally has at least 15 years of pharmaceutical industry/drug development experience
At least 8 years of compliance and process management experience
At least 5 years management experience of a global team
Excellent knowledge of global GxP practices required - Good Clinical Practices, Good Pharmacovigilance Practices, European Medicine Agency requirements, as well as regulatory requirements regarding computerized systems (21 CFR Part 11 and EU Annex 11) used for regulatory submission
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
Preferred
Advanced degree in a scientific discipline preferred
Benefits
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
Company
UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.04M2017-11-27Acquired
2010-08-13Series Unknown· $0.04M
Leadership Team
Bekki Brown
Chief Executive Officer
Nicole Hebbert
SVP, Head of Patient Support Services
Recent News
Venture Capital
2026-01-06
Company data provided by crunchbase