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us: Director, Quality Assurance [BSc in life sci or medically related field; 7-10y exp; mgmt exp, SOP Mgmt/Document Control and SOP writing, electronic document mgmt SW, processes and SW validation; Manage, develop and maintain quality assurance program, coordinate Global SOP/document mgmt process, mentor team members, Travel minimum 35%] / United BioSource Corporation; Bethesda, MD and Lexington, MA or Wayne, PA / NO AGENCIES!

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Director, Quality Assurance

Job Code : 739
Division : UBC – Health Care Analytics
Location : Bethesda MD US 20814
% of Travel Required : 30-40%
Job Type : Full Time
Career Level : Manager (Manager/Supervisor of Staff)
Education : Bachelor’s Degree
Category : Biotechnology and Pharmaceutical

Job Description :

Employees Create the Evidence that Matters

As demand for the rapid delivery of new pharmaceuticals, biotechnology and medical devices to identify, treat and prevent disease is on the rise, never has the need for conclusive evidence of product efficacy and effectiveness been greater. United BioSource Corporation is focused on meeting this growing demand for evidence.

UBC: a fast growing, full range, global pharmaceutical services organization.

Delivering evidence-based services and solutions depends on the quality and dedication of our staff. We seek the brightest, most talented professionals in the industry.

Whether you are launching a career or seeking new challenges, UBC fosters personal and professional growth on diverse and challenging projects amid highly respected scientific, clinical and data professionals, and offers a robust compensation and benefits package.

Come join our team to deliver the scientific evidence helping products succeed in the real world and saving millions of lives because Evidence Matters.

Position Overview:

The Director, Quality Assurance will: Manage, develop and maintain quality assurance program for assigned customer projects at a regional and/or global level; Oversee and coordinate the Global SOP / document management process; Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites; Act as line manager for one or more QA staff. This position would be based out of Bethesda, MD, Lexington, MA or Wayne, PA

Essential Duties and Responsibilities:

• Develops, implements and directs processes / best practices related to SOPs to ensure regulatory compliance and strong customer service across all functional business units.
• Directs, develops and implements training on new / enhanced SOP management processes.
• Provides expertise as needed to customers during the development of new SOPs.
• Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work.
• Ensures that staff has the proper materials, systems access and training to complete job responsibilities. Provides oversight for the execution of position required training and that training binders are complete.
• SOP review and mentored training experiences, as applicable.
• Acts as a coach and mentor for team members as they develop in their role. Works collaboratively across business functions to manage SOP related challenges and to achieve exemplary customer service.
• Manages the quality of assigned staff’s work through regular review and evaluation of work product. Ensure staff are meeting defined workload and quality metrics through regular review and reporting of findings.
• Identifies quality risks and issues and creates appropriate corrective action plans to prevent or correct deficiencies
• Acts as customer liaison during pre-assessment audits/project audits and develops corrective action plans
• Provides support for process to provide responses to request for information and proposals as necessary.
• Participates in or leads (cross functional) teams for special projects as assigned.
• Provides QA guidance regarding IT related processes
• Provides guidance, interpretation, support, training, and key input to staff on interpretation of GCP regulations, guidelines, quality system requirements, corporate standards, and policies.
• Oversees documentation, reporting, and closure of compliance issues.
• Conducts vendor qualification audits as well as periodic assessments
• Supports Quality Management with reporting QA metrics.
• Conducts trend analysis of audit results and provides QA management with initial root cause analysis
• Travel a minimum of 35%.

Job Requirements :

• Bachelor’s degree in life sciences or medically related field; or equivalent paramedical qualifications; with 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience.
• A minimum of 3 years of management experience working with a global team; or equivalent combination of education, training and experience.
• Experience in SOP Management / Document Control and SOP writing
• Knowledge of process improvement and project management methodologies.
• Strong technical / medical writing skills including knowledge of SOP writing.
• Knowledge of electronic document management software, processes and software validation.
• Basic understanding of GCPs & pharmaceutical research and development processes.
• Advanced knowledge of the applicable word processing, spreadsheet, graphic, publishing and/or web publishing software and database applications
• Ability to work in a global, multi-time zone, highly diverse environment.
• Ability to work independently as well as in a team environment including multi-level personnel.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to manage staff and costs effectively through appropriate resource allocation
• Considerable knowledge of quality assurance processes and procedures.
• Strong interpersonal, organization, communication, team orientation and leadership skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Ability to influence and guide others.

The Health Care Analytics values a team-oriented, collaborative approach in its work. The candidate will have an opportunity to work with leaders in the field of pharmacoeconomics and health outcomes research. We offer a competitive compensation package as well as the necessary resources and rewards to enhance your career. United BioSource Corporation is an Equal Opportunity Employer.

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