Director - Quality Compliance (Patient Support Services)

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Job description

*This position will oversee the Quality Compliance group at the Director level on the Patient Support Services/Commercial side of UBC business.

*Job Title: *YRC99J - Director, Regulatory Quality Compliance

*Brief Description*:

Responsible for developing and implementing 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 Late Stage activities and provides Senior Management with in-depth analysis and risk management on quality matters. Leads a team of Quality Assurance & Compliance professionals, setting and communicating the vision for the team and fostering a culture of collaboration. Reports to Senior Leader.

*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.
* Effectively manage the development, implementation 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.
* 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
* 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.
* 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
* 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 Responsibilities*:

Supervision of Quality Assurance staff

*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, 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.
* Knowledge of ICH GCP Guidelines, Good Pharmacovigilance Practices and FDA Regulations
* The ability to work autonomously with minimal supervision.

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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*ABOUT UBC*

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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