PharmaLex
Sr Compliance Specialist – PharmaLex
Overview Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
Responsibilities
Develops, implements, administers and certifies compliance policies, procedures, and practices.
Ensures alignment with legal and ethical standards of the organization, provides compliance advice, investigates complaints and verifies deficiencies are corrected.
Develops employee communication and training programs that focus on the elements of a companywide compliance program.
Enforces antibribery and anticompetition laws.
Analyzes metrics and audits functional compliance program.
Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.
Preferred Qualifications
8+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem‑solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Outstanding communication and interpersonal skills, capable of effectively working with cross‑functional teams and external stakeholders.
Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability.
Skills
Autonomy – works independently under limited supervision, coaches and reviews the work of lower level specialists, may manage projects/processes.
Organizational Impact – may be responsible for entire projects or processes within job area, contributing to work group objectives.
Innovation and Complexity – solves difficult problems, improves processes, systems or products, provides in‑depth analysis and recommendations.
Communication and Influence – communicates with senior internal and external customers and vendors, influences decision‑making.
Leadership and Talent Management – may provide guidance, coaching and training, may manage projects and delegate work.
Required Knowledge and Experience – advanced knowledge of job area combining breadth and depth, typically obtained through advanced education and experience.
Shift 1st
Location Juncos, PR
Education BS in Science or Engineering
Employment Type Full‑time
Seniority Level Mid‑Senior Level
Contract Details This position is for a fixed‑term contract supporting one of ECHO Consulting Group (an A Cencora company) partners on site at their facility.
Benefits We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. Training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more are also available. For details, visit https://www.virtualfairhub.com/cencora.
Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. We will make reasonable accommodations to individuals with disabilities during the employment process in accordance with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com.
Contact For accommodation requests only, please contact 888.692.2272.
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Overview Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
Responsibilities
Develops, implements, administers and certifies compliance policies, procedures, and practices.
Ensures alignment with legal and ethical standards of the organization, provides compliance advice, investigates complaints and verifies deficiencies are corrected.
Develops employee communication and training programs that focus on the elements of a companywide compliance program.
Enforces antibribery and anticompetition laws.
Analyzes metrics and audits functional compliance program.
Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.
Preferred Qualifications
8+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem‑solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Outstanding communication and interpersonal skills, capable of effectively working with cross‑functional teams and external stakeholders.
Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability.
Skills
Autonomy – works independently under limited supervision, coaches and reviews the work of lower level specialists, may manage projects/processes.
Organizational Impact – may be responsible for entire projects or processes within job area, contributing to work group objectives.
Innovation and Complexity – solves difficult problems, improves processes, systems or products, provides in‑depth analysis and recommendations.
Communication and Influence – communicates with senior internal and external customers and vendors, influences decision‑making.
Leadership and Talent Management – may provide guidance, coaching and training, may manage projects and delegate work.
Required Knowledge and Experience – advanced knowledge of job area combining breadth and depth, typically obtained through advanced education and experience.
Shift 1st
Location Juncos, PR
Education BS in Science or Engineering
Employment Type Full‑time
Seniority Level Mid‑Senior Level
Contract Details This position is for a fixed‑term contract supporting one of ECHO Consulting Group (an A Cencora company) partners on site at their facility.
Benefits We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. Training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more are also available. For details, visit https://www.virtualfairhub.com/cencora.
Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. We will make reasonable accommodations to individuals with disabilities during the employment process in accordance with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com.
Contact For accommodation requests only, please contact 888.692.2272.
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