Additional locations: us-ca-valencia; us-mn-maple grove
Diversity - innovation - caring - global collaboration - winning spirit - high performance
At boston scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challengesWith access to the latest tools, information and training, we’ll help you in advancing your skills and careerHere, you’ll be supported in progressing – whatever your ambitions.
Principal specialist, clinical quality assurance
About the role:
The clinical quality assurance principal position is a leadership role supporting internal clinical quality assurance program and quality systems for the assigned divisional business areaThis includes clinical compliance, internal and external quality audits, inspection readiness program, and, supporting clinical corrective and preventative action (capa) and acquisition integration.
Please note that this role can be based at any bsc location or remote home based
Your responsibilities include:
Clinical compliance:
Hands on partnership with pms for inspection readiness
Participate on clinical project teams to foster and inspire clinical teams towards a state of inspection readiness at all times.
Consultant support for compliance and regulation questions including quality review of clinical study documents
Facilitate inspection readiness program to include inspection readiness training and facilitate/coordinate mock bimo inspections.
Manage/coordinate bimo sponsor inspection, and other regulatory agency sponsor inspections of bsc offices.
Preparation of investigator sites for fda or other regulatory agency inspections and assists in preparation of written responses to findings.
Communicate with global clinical teams and strategic sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
Independent auditing
Plans, schedules, and conducts external quality audits to assure that bsc clinical investigations comply with all applicable regulatory requirements and bsc policies and procedures.
Plans, schedules, and conducts internal quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
Plans schedules and conducts clinical vendor assessments, qualification and periodic.
Review, revise, update and maintain clinical avl
Documents audit observations; evaluates impact and makes recommendations for corrective actionsEvaluates responses to audit findings and ensures that appropriate corrective actions are completed.
Communicates observations to clinical investigators, clinical program managers, directors, and management
Contributes to the development of audit procedures and processes.
Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
Clinical quality system:
Support to the clinical organization in meeting bsc quality system requirements
Support clinical and qs team during external regulatory/notified body audits
Capa program; assessing internal noncompliance recommending initiation of nceps, clinical capa team member working cooperatively with ncep/capa owners providing quality input.
Acquisition integration:
Act as the clinical quality lead on clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with quality project lead integration of quality system elements.
Supports clinical teams in gathering and reporting various performance metrics by preparing slides and overall health statement for quarterly business unit management review meetingsAssess and provide relevant information for inclusion in the quarterly executive committee management review.
Participates on clinical process improvement projects and initiatives.
Supports departmental, divisional, and corporate quality goals and priorities.
What we’re looking for in you:
Bachelor’s degree and 8+ years relevant experience preferably in medical device industry
5 years clinical quality assurance experience preferred with clinical quality (gcp) auditing experience, or, equivalent/applicable bsc internal clinical research experience
Ability to communicate with all levels of the organization
Domestic and international travel up to 30-50%Note: covid-19 precautions currently restrict travelAt boston scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.
Requisition id: 504361
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human lifeOur mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operateNow more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with boston scientific (nyse: bsx) isn’t just business, it’s personalAnd if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At boston scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient healthThat is why we stand for inclusion, equality, and opportunity for allBy embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serveBoston scientific is proud to be an equal opportunity and affirmative action employer.
Boston scientific maintains a drug-free workplacePursuant to vaCode § 2.2-4312 (2000), boston scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Job segment: clinic, medical, law, capa, healthcare, quality, legal, management
