[Hiring] Sr. Director, Global Quality Compliance - Biotech/Pharma @United Biosource Corporation

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 being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. 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: YRC99K- Sr Director, Regulatory Quality Compliance Brief Description: Responsible for developing and implementing global strategy and policy relative to quality management systems for UBC to ensure excellence in compliance and the ability to withstand internal and external scrutiny as well as to provide quality services for sponsor. Ensures that internal controls are implemented and are evaluated for compliance via audits and assessments across the UBC functions to minimize regulatory, legal and business risk while effectively and efficiently supporting business goals. Develops auditing/inspection strategies for UBC activities and provides management with in-depth analysis and risk management on quality matters. Leads a global team of Quality Assurance & Compliance professionals, setting and communicating the vision for the team and fostering a culture of collaboration. Specific job duties:

• Accountability - Defines quality objectives and strategies to meet customer requirements and UBC goals and objectives.
• Change Management - 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
• Continual Improvement - Generates creative new solutions and approaches to customer issues and organizational quality processes.
• Partnering/Networking Participates in cross-functional activities to achieve organizational objectives.
• Systems Thinking - 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.

Supervisory Responsibility:

• Supervision of Global Quality Compliance, Training and Information Technology Quality Compliance Staff

Desired Skills and Qualifications:

• Bachelor's degree in a life science required; advanced degree in a scientific discipline preferred. Generally has at least 15 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 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.

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
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