CAPA Manager

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: reputed company reputed company Job Posting Locations: Horsham, reputed company, reputed company of America, Malvern, reputed company, reputed company of America, New reputed company, New Jersey, reputed company of America, Raritan, New Jersey, reputed company of America, Spring House, reputed company, reputed company of America, Titusville, New Jersey, reputed company of America Job reputed company: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of reputed company. Join us in developing treatments, finding cures, and pioneering the reputed company from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine This is a remote and/or hybrid role available in New Jersey and reputed company. While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review where this opportunity is available: Horsham, PA Malvern, PA New reputed company, NJ Raritan, NJ Titusville, NJ We are searching for the best talent for a CAPA Manager. The CAPA Manager will support Delivery reputed company, and its Investigation Owners (IO) in the Corrective reputed company Preventive reputed company (CAPA) development and implementation process as a reputed company result of audits, inspections, and self-identified issues for both in-house and outsourced trials with a regional/global scope. He/she will reputed company the Nonconformance/CAPA process and serve as the CAPA process expert for investigation owners through nonconformance identification, investigation, execution, and reputed company. Key Responsibilities: reputed company as CAPA Champion reputed company regional/global roles in DUs are assigned as Investigator Owners of a nonconformance. reputed company as process and system SME for the nonconformance and CAPA process and business/system requirements. Assist the Investigation reputed company in the application of reputed company problem? solving methodologies in reputed company Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc.) independently or in support of the reputed company Cause Investigation team. reputed company the Investigation reputed company in understanding their end-to-end accountability of the entire CAPA process. reputed company and maintain proficiency in the reputed company. Work with the organization to identify resources to support RCA investigations and resulting actions. reputed company assistance to the Investigation reputed company to ensure process requirements are met. Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to reputed company drive compliance. reputed company as a reputed company between the IO and the reputed company leader; the IO and the reputed company Cause Analysis group; the IO and the Central Data Entry team. Escalate any issues, as needed, to the R&D reputed company CAPA Review reputed company and attend the meetings if required. reputed company any process or system questions or concerns to the CAPA Champions Community of reputed company. Collaborate with other CAPA Managers/Champions in the management of reputed company CAPAs and process reputed company activities. Manage requests for assistance from the Central Data Entry team on behalf of the IO. reputed company Relationships: Contacts inside reputed company include but are not limited to: Various roles across Delivery reputed company, GCO, R&D reputed company and Strategic Partnerships. Contacts reputed company reputed company: Strategic partners as applicable, including CROs and study site staff as needed. The CAPA Manager reports into the Functional Manager in the Delivery Unit. Requirements: Education A minimum of a Bachelor s Degree in Science (BSc) or Arts (BA) and a minimum of 7-8 years of previous Pharmaceutical Industry experience is required, with at least 3-4 years of GXP experience reputed company clinical research and development and/or reputed company assurance. reputed company Experience Experience in reputed company Control and Compliance, reputed company Assurance, CAPA process and/or reputed company Cause Analysis. reputed company-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities). Experience in reputed company assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset. Ability to translate data into information and strategies into executable reputed company plans improving the business. Ability to motivate reputed company colleagues and stakeholders. Conflict reputed company/management and negotiation skills. Ability to independently plan, organize, coordinate, manage and execute assigned tasks. Experience of the key customers business processes and practices. Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines reputed company to clinical development. Strong personal leadership skills with demonstrated competency interfacing with reputed company reputed company of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an reputed company and inviting environment; Embraces generational differences. Demonstrated project leadership skills. General Skills Problem solver Excellent organization skills Excellent written and verbal communication skills Excellent independent time management skills Proven ability to plan and reputed company deliverables and timelines Ability to work reputed company in a dynamic environment and reputed company to prioritize and respond to changing needs of the business Problem solver Strategic thinker Leader and collaborator Highly committed to reputed company Flexible and persistent Good conflict handling/negotiation skills reputed company to create win-win situations with reputed company partners. Knowledge of the corporate structure and culture Other Skills and Abilities Requires limited supervision and functions with autonomy. May directly or indirectly reputed company or supervise other employees for small reputed company/teams. Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service. Excellent knowledge of English is required. Proficient in reputed company Office applications reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us reputed company https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. #LI-Remote Required Skills: Preferred Skills: Analytical Reasoning, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution reputed company, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, reputed company Operating Procedure (SOP), Technical Credibility The anticipated reputed company pay reputed company for this position is : $117,000.00 - $201,250.00 Additional reputed company for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in reputed company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits Apply To This Job