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Quality Assurance & Compliance Specialist (Pharma Industry) | QA in Quality Assurance Job at M1

This listing was posted on The Resumator.

Quality Assurance & Compliance Specialist (Pharma Industry)

Location:
Canton, MI
Description:

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry background and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across 4 continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more info, visit www.mmsholdings.com or follow MMS on LinkedIn . Assigned Responsibilities May Include: Provide Quality Assurance (QA) oversight and consultation. Provide GxP compliance oversight and consultation; regularly assessing current regulations and new/updated regulations to ensure that your client(s) are meeting the qualifications for all applicable legal and regulatory obligations. Interact directly with clients, independently or as part of a team, demonstrating strong leadership, providing expert knowledge, and advising on current industry and clinical trial qualifications and best practices. Review and support development of Sponsor/vendor agreements (e.g., Statement of Work [SoW], Quality Agreements, Data Processing Agreements [DPA], Oversight Plans, Transfer of Regulatory Obligations [TORO], etc.) Manage or assist with all elements of a client’s Quality Management System (QMS), including but not limited to issue reporting and corrective action tracking & trending; risk management; document & record control; quality metrics and Key Performance Indicators (KPIs); management review; vendor management; complaints & recalls; product review; etc. Develop, review/assess, and maintain Standard Operating Procedures (SOPs), and other documentation and training materials related to GxP compliance and other applicable qualifications. Manage or assist with learning management system administration, training record maintenance, and training compliance. Manage or support audits and inspections by regulatory authorities or other external agencies. Support/advise client on responding to agency queries and inspection observations and other health authority communications. Manage or support internal audits, including planning, conduct, preparing/reviewing/finalizing internal audit reports, and ensuring proper closure of any observations. Manage or assist with client’s vendor management program, ensuring adequate vendor qualification, monitoring, and oversight is conducted and quality is maintained per client procedures and applicable regulatory qualifications. Perform Quality Control (QC) and/or QA review of scientific documents and reports, as requested. Participate in company and departmental process improvement initiatives and recommend suggestions to improve the QMS. Represent self and company in a professional manner and in line with core company values. Practice excellent internal and external customer service, communication, and team work. Support objectives and improvement efforts within department and organizationally. Qualifications: Bachelor’s degree in biomedical, nursing, or scientific discipline; 5+ years of background in a QA, Auditing, or GxP Compliance role within a pharmaceutical company, health authority, and/or relevant CRO with direct background leading and/or performing the activities listed above; In depth knowledge of Sponsor quality and regulatory obligations throughout the drug development life-cycle and clinical trial operations; In depth knowledge of pharmaceutical industry and clinical trial guidelines and regulations (e.g., ICH GCP, CFR Title 21, etc.); Strong verbal and written correspondence skills; Proficient with Microsoft office suite applications; and Excellent management skills, detail-oriented, expertise to prioritize and multi-task. In addition to the qualifications above, the ideal candidate would also have or be willing to attain the following as applicable: Advanced degree in QA, Regulatory Affairs, or scientific discipline; and/or certification from a quality or regulatory organization (e.g., ASQ); Working expertise of data privacy laws and regulations (e.g., GDPR); Current understanding of ex-US pharmaceutical guidelines and regulations (e.g., EMA, MHRA, PMDA, JPMA, etc.); Current knowledge of other related qualifications (e.g., GLP, GMP, GVP, GDP, ICH, devices, over-the-counter, cosmetics, etc.); and Familiarity with ISO 9001, 27001, 15378, & 13485 standards
Company:
MMS Holdings
Posted:
November 15 on The Resumator
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More About this Listing: Quality Assurance & Compliance Specialist (Pharma Industry)
Quality Assurance & Compliance Specialist (Pharma Industry) is a Quality Assurance QA Job at MMS Holdings located in Canton MI. Find other listings like Quality Assurance & Compliance Specialist (Pharma Industry) by searching Oodle for Quality Assurance QA Jobs.