Clinical Quality Systems Mgr - 16752

Job Description: General Summary: Responsible for the management of the Clinical Quality Assurance (CQA) function in assigned business area(s) in line with strategies and goals set by global CQA management. Ensures clinical research activities conform to federal and international regulations and BSC procedures and expectations.

Principal Duties and Responsibilities:
? Provides functional oversight to the Clinical QA function in assigned business area.
? Participates in the development, implementation and maintenance of global quality systems.
? Ensures development, implementation and maintenance of local quality systems, policies and procedures that ensure compliance with Good Clinical Practice (GCP), ICH, and all applicable regulations.
? Ensures consistency of activities between all CQA locations.
? Works with Clinical Senior Management to gain acceptance of quality procedures.
? Works with Clinical Program Managers/Project Managers to understand needs, establish priorities, and plan resource requirements.
? Partners with clinical project teams to develop trial quality assurance plans to ensure compliance of company sponsored clinical studies to global regulations and Good Clinical Practice (GCP) guidelines.
? Performs and/or manages internal and external audits (internal systems, trial master file, investigator sites, clinical service providers) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
? Documents audit observations and makes recommendations for preventive and corrective action.
? Evaluates responses to audit reports and ensures timely and appropriate implementation of corrective actions.
? Identifies key areas of regulatory risk and suggests potential resolutions.
? Identifies and implements quality improvements that address weaknesses or exposures revealed through QA activities; Identifies ways to improve compliance with regulations and BSC policies and procedures.
? Provides input to training function and where appropriate, gives training on issues identified during audits.
? Supports the preparation, coordination and management of Regulatory Agency inspections at clinical sites and BSC offices. During inspection, plays lead role as facilitator and communicator.
? Acts as a consultant relative to the interpretation of regulations and their implementation.
? Reviews SOPs to assure compliance with regulations and BSC policies and procedures.
? Prepares sites for FDA or other regulatory agency inspections, and assists in the preparation of written responses to findings.
? Keeps abreast of regulatory requirements and updates management on the possible ramifications of regulatory changes.
? Develops department plans and budgets and monitors spending.
? Recruits, trains, supports, and develops Clinical Quality Assurance staff (Auditors and Specialists).
Secondary Duties and Responsibilities:
? Performs and/or manages vendor assessment/qualification audits prior to contract initiation.
? Participates in due diligence evaluations and audits of potential outside collaborations, joint ventures, acquisitions, or in-licensed products.
? Participates in periodic site visits to assess the site's understanding of GCPs and protocol requirements.
? Assists in training for Clinical Affairs staff and/or contractors, as needed.
? Presents GCP and protocol-specific training at investigator meetings.
? Maintains a database of compliance review findings, reports, files; Summarizes and analyzes data for trends and provides quarterly updates to management.
? Reviews essential documents such as protocols, CRFs and informed consent forms for adequacy and compliance with GCP and regulations.
? Engages, trains, and supervises contract auditors, as necessary.
Minimum Education & Experience:
? Bachelor's degree in science or health related field required; advanced degree preferred.
? Minimum of eight years experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 3+ years clinical QA and/or compliance experience; 2+ years auditing experience; international experience a plus.
? Management experience in clinical trial operations required.

Working Conditions:
General office environment; Approximately 30% domestic and international travel required.

Key Customers:
Clinical research management and clinical program teams

Key Performance Measures:
? Timely and effe

Job Experience:
Competency Expectations:
? Strong knowledge of Good Clinical Practices (FDA and ICH), good understanding of 21CFR Part 11 with respect to clinical processes and systems. Familiar with government compliance programs, EU Directives, HIPAA and Subject Data Protection regulations and laws.
? Working knowledge of the drug/device development process and clinical trial operations.
? Proven verbal and written communication skills; medical and/or regulatory writing experience.
? Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
? Leadership and interpersonal skills; ability to interact with all levels of management.
? Mature, problem-solving attitude; exhibits judgment and a realistic understanding of the issues; able to use reason even when dealing with emotional topics.
? Ability to understand strategic goals and match the business needs of the company.
? Ability to develop good interpersonal relationships with medical professionals.
? Able to interpret company policies and procedures to make independent decisions.
? Proven ability to work on multiple projects simultaneously and set priorities.
? Able to train other auditors and clinical research staff.
? Detail orientation; highly organized; self-starter.
? Computer proficiency in a Windows environment (Microsoft Project, Excel, Word, Powerpoint, Visio, Outlook)

Searchable Keywords: Clinical Quality Systems Mgr - 16752 / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: None

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.