Job details
Salary $93,000 - $139,000 a year
Full job description
Johnson & johnson bioresearch quality and compliance quality assurance (qa) is recruiting for a manager qa auditor, to conduct gcp audits, to support the cardiovascular & specialty solutions (css) group, part of the medical devices sectorsThe position is located in the united statesThe preferred locations are irvine, ca open to other us j&j locations or remote us location.
Our mission is to build qa of the future by transforming the bioresearch quality & compliance (brqc) audit function to be industry-leading and by delivering innovative ways to proactively secure compliance and drive sustainability and reliability across r&d.
Quality assurance is responsible for the implementation and delivery of global cross-functional compliance audit programs to ensure that the development programs, marketing authorization holders, functions, processes, and systems for css (and all partners) are in compliance with company standards and health authority guidelines and regulationsFor more information, visit
The css group consists of six diverse businesses including advanced sterilization products (asp), acclarent, biosense webster, codman neuro, mentor, and sterilmedThe css group serves a diverse base of customers in ear, nose and throat (ent), infection prevention, electrophysiology, surgical and non-surgical aesthetics, neurovascular, and reprocessingThe css group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world.
Auditing:
Independently leads the planning, conducting, and reporting of assigned bioresearch gcp qa routine and non-routine gcp audits including clinical investigator site, trial/program, external service provider, process/system and local operating country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirementsNon-routine audits may include due diligence, for-cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
Assists in preparation and presentation of training materialsSupports the development and mentorship of other auditors.
Ensures the standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
Analyzes interpret data and identify patterns and trends in data sets.
Ensures timely and appropriate review & delivery of capas and actions arising from audits.
Presents information logically and concisely, both verbally and in the writing of issued reports.
Inspection support:
Supports regulatory inspections in lead or supporting roleConducts pre-inspection visits.
Collaborates with clinical operations to ensure that investigational sites, cro’s, and internal organizations are ready for regulatory inspections
Training & development:
Mentors and facilitates successful team behavior within and across functional areaMaintains relationships externally and internally for functional areaBuilds cross-functional and cross-departmental support for innovative solutions.
Develops or is involved in the review and approval of training curriculum as applicable to the area(s) of expertise.
Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
Provides coaching, useful feedback, and direction to teams.
Supports other auditors in planning, conduct and reporting of audits
Cultivates harmony within functional and other areasPromotes the business value of diverse perspectives.
Influences and persuades to bring about the process and technical improvements
Project management:
Takes an active role in projects as assigned by supervisor
Represents the department/project in providing solutions to difficult technical issues.
Support pre/post acquisition activities, if applicable
Defines complex issues & develops strategies to address these issues; manages departmental/projects day-to-day operations within area of responsibility, and interrelationship between functions.
Subject matter expert / point of contact:
Maintains good communication and provides expertise and knowledge to less experienced auditors, business partners and the core business sector on quality and compliance processes/procedures.
Interprets and applies regulations/ policies to issues of moderate complexity, when required.
Provides gcp audit strategy support, especially on qa risk-based auditing approach (audit plans)
Qualifications
Bachelor`s degree required; advanced degree in scientific, medical or related field preferred.
Minimum of 8 years of experience working in clinical quality & compliance, clinical operations, and/or related r&d area is required.
Experience in the medical device industry is required.
Knowledge of good clinical practices (gcp) and applicable regulations/guidelines (e.g., fda regulations, iso 14155, ich e6) is required
Computer literacy & analytics - experience using standard applications/systems required; data analytics tools is preferred.
Understanding of fundamentals of clinical trial risk management is required
Experience conducting clinical quality assurance audits is preferred
Ability to effectively negotiate and influence upper management, affiliates and regulatory agencies to ensure that regulatory and business needs are met is preferred
Creative thinking relative to new and emerging technologies and analytics, and ability to find opportunities where creative capabilities may be applied within qa audit processes is preferred
Inspection support experience (fda, ema and other inspectorates) is preferred
Excellent networking, communication, organization, investigation, and negotiation skills are required
Ability to plan and prioritize work in an efficient manner and work well under time constraints is required.
Travel up to 20% required primarily domestic us
Johnson & johnson is an affirmative action and equal opportunity employerAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The base pay range for this position is $93,000 to $139,000.
The company maintains highly competitive, performance-based compensation programsUnder current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable planThe annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance yearBonuses are awarded at the company’s discretion on an individual basis.
Employees may be eligible to participate in company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plansAdditional information can be found through the link below.
Primary location
United states-california-irvine-31 technology dr
Other locations
North america-united states
Organization
Biosense webster inc(6010)
Job function
Quality
Requisition id
2105973793w
