Manager, Compliance and Quality
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
With direction and oversight from the Executive Director - Compliance and Quality or designee, the Manager, Compliance and Quality is responsible for working with Advanced Clinical staff in the planning, conduct, and follow-up of internal audits; ; supporting regulatory inspection readiness activities including planning, hosting, and follow-up of regulatory inspections of Advanced Clinical and its clients, as applicable; Quality Management Systems (QMS) consulting to Advanced Clinical staff and clients; and overall support of daily QMS activities, as directed.
The Manager, Compliance and Quality is responsible for the day to day management of Advanced Clinical QMS activities, i.e. Client Audit Management, Internal Audit Management, SOP Management, Vendor Management, CAPA Management, etc. The Manager - Compliance and Quality will review and approve QMS deliverables, including audit plans and reports.
The Manager, Compliance and Quality is the primary point of contact for internal Advanced Clinical staff, is a model of regulatory and quality systems compliance, and should function as a subject matter expert and advisor to his or her colleagues throughout the organization. In addition, the Manager, Compliance and Quality may also be responsible for directing or mentoring applicable staff and/or contractors/consultants.
- Support Compliance and Quality Management in the execution of QMS Activities
- Manage Compliance and Quality staff, as assigned
- Support, execute, lead, and manage all aspects of the client audit process
- Manage all aspects of the Noncompliance/CAPA process including assignment, tracking, consultation with staff including root cause analysis, follow-up and closure of Noncompliances/CAPAs
- Ensure Advanced Clinical SOPs are created, reviewed, revised, approved, and retired according to the SOP review schedule
- Ensure assigned Compliance and Quality staff complete internal audits, vendor audits, validation assessments, and other scheduled QMS activities according to stated timelines
- Support and manage vendor management activities including ensuring tracker is up to date, coordinating with Advanced Clinical staff on vendor requests, ensuring required documentation is completed and filed appropriately
- Assist in supporting all aspects of regulatory inspections at Advanced Clinical and Advanced Clinical clients, as assigned
- As applicable, train Advanced Clinical staff
- Ensure staff training documentation is maintained according to Advanced Clinical processes
- Update applicable departmental trackers, as assigned
- Support Compliance and Quality Management with metrics tracking and reporting, as needed
- Maintain GxP knowledge and expertise relevant to applicable local and international regulations
- As needed and feasible (based on departmental workload), perform or assist with other tasks, programs, initiatives, or assessments as assigned by Compliance and Quality management or applicable executives.
The candidate must be fluent in English.
- Education: Bachelor's or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is required. An advanced degree is preferred.
- Training: Current documented training in GCP or completion during new hire onboarding; additional documented training in either GMP or GLP would be beneficial.
- Certification: Has or will obtain within one year of hire, at least one relevant certification (CQA, RQAP, RAC, etc.)
- Experience: At least five years of industry experience including pharmaceutical or CRO management and auditing experience related to one or more of Good Clinical Practices, Good Manufacturing Practices, or Good Laboratory Practices; experience writing/implementing SOPs; global regulatory inspection experience preferred. Experience working with remote and global staff preferred.
Our Culture: https://careers.advancedgroup.com/embrace-our-culture
Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group's career site here .
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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