Quality Assurance Manager

Resonant Inc.•Sterling, VA

About The Position

The Manager - Quality Assurance is responsible for providing guidance, support, and expertise in maintaining regulatory compliance according to established standard operating procedures and applicable regulatory requirements. The Manager - Quality Assurance should develop a sense of responsibility toward their duties How will you make an impact & Requirement POSITION REQUIREMENTS: Bachelor’s degree or at least 5 years of relevant work experience. At least 5+ years of applicable work experience. At least 3+ years of experience in quality, auditing and/or project management. Demonstrated experience and working knowledge of applicable regulations as they relate to EPL Archives services. Strong communication skills (both written and oral). Ability to work independently when necessary and participate in a team environment. Ability to balance and coordinate workload for multiple projects. Ability to maintain strict confidentiality regarding all matters concerning the company, its customers, and employees. Ability to use Microsoft Office (Word, Excel and PowerPoint). Superior role model leadership behaviors – ability to lead and motivate others while displaying integrity, intensity, innovation, and involvement. GENERAL POSITION DUTIES: The Manager - Quality Assurance is responsible for providing guidance, support, and expertise in maintaining regulatory compliance according to established standard operating procedures and applicable regulatory requirements. The Manager - Quality Assurance should develop a sense of responsibility toward their duties to include the following: Completion of the orientation program with: An understanding of our work and how it must be completed in compliance with applicable US and OECD regulations and our Standard Operating Procedures. An understanding of Chemical Safety and the proper use of safety equipment. An understanding of EPL Archives’ quality program requirements, including the following: Communication of the company's quality program to internal and external stakeholders. Participation in the development of processes and procedures that meet quality standards. Participation and/or oversight of regulatory training and development. Participation and/or oversight of company audit programs. SPECIFIC POSITION DUTIES: Develops and manages the quality strategy for the site(s) in alignment with quality function and overall Company goals. Helps create a quality-focused culture through collaboration, training, metrics, and risk-based assessments. Works with various functions, including operations, client services, facilities, and IT to develop, implement, and continuously improve the Quality Management System. Manage the development of quality assurance staff, including coaching and development recommendations through performance reviews. Manage the daily operation of the quality assurance unit, including maintenance of an effective system for completion of day-to-day work assignments, indexing of quality assurance records and oversight of the regulatory training program. Manage/assist with the evaluation of overall compliance of the EPL Archives facility with applicable standard operating procedures (SOPs) and regulatory requirements through internal facility and process focused inspections. Ensure proper distribution of findings to Archives Management personnel and staff for resolution, including initiation of SOP changes based on inspection findings. Develop/coordinate changes to SOP’s, controls, and procedures sufficient to successfully satisfy any audit or other regulatory review performed by FDA, EPA, and other agencies with significant authority to conclude on the business operating compliance with complex regulations. Manage/provide oversight for Corrective Action Investigations. Lead and coordinate regulatory/client/facility audit response and SOP Updates between EU/US sites, ensuring continuity of procedures between sites. Provide oversight for the maintenance of all inspection activity records; identify, document and report deviations from applicable regulations and standard operating procedures to Archives Management; ensure appropriate corrective actions have been completed. Provide oversight for the collection and distribution of periodic reports to Archives Management which summarize deviation trending, client complaints and corrective action investigations status. Develop and manage Vendor Assessment Program, including the scheduling/conducting of critical vendors/supplier assessments for suitability of use, distribution of findings to Archives Management personnel and vendors for resolution. Serve as QA lead for client inspections and perform associated duties (e.g., agendas, summary reports, and follow-up to ensure resolution of findings). Primary point of contact with responsibility to manage regulatory inspections and perform associated duties (e.g., daily summary reports, copying of materials). Participate as a subject matter expert of the Management Technology Board. Provide oversight/assist in the development of testing for associate compliance and working understanding of regulatory requirements. Research and attend seminars and/or courses necessary to develop growth in the Quality Assurance field. Participate and, when able, exhibit at quality assurance conferences to share and learn best practices within the quality assurance industry. Research and communicate to internal management current trends in quality assurance areas and emerging topics of focus impacting QA practices. Take part in company planning activities and/or committee assignments. Review Non-Disclosure Agreements and Quality Agreements in conjunction with legal team to support business needs. Develop, monitor, and manage approved department budget. We are an Equal Opportunity Employer. At Resonant, we're more than a leading life sciences company. We're a global team dedicated to the uncompromising pursuit of quality to help our customers deliver on their mission: moving science forward. With touch points and products across clinical trial and diagnostic services - sourcing, supply chain and storage - we collaborate to solve our customers' most complex challenges. Want to join more than 850 dedicated Resonant team members (and growing) worldwide? Whether you bring the life sciences background or proven operations know-how, consider advancing your career with Resonant in one of our available roles. Join us in our mission: to help clients move their life science programs forward with clarity and purpose.

Requirements

Bachelor’s degree or at least 5 years of relevant work experience.
At least 5+ years of applicable work experience.
At least 3+ years of experience in quality, auditing and/or project management.
Demonstrated experience and working knowledge of applicable regulations as they relate to EPL Archives services.
Strong communication skills (both written and oral).
Ability to work independently when necessary and participate in a team environment.
Ability to balance and coordinate workload for multiple projects.
Ability to maintain strict confidentiality regarding all matters concerning the company, its customers, and employees.
Ability to use Microsoft Office (Word, Excel and PowerPoint).
Superior role model leadership behaviors – ability to lead and motivate others while displaying integrity, intensity, innovation, and involvement.

Responsibilities

Develops and manages the quality strategy for the site(s) in alignment with quality function and overall Company goals.
Helps create a quality-focused culture through collaboration, training, metrics, and risk-based assessments.
Works with various functions, including operations, client services, facilities, and IT to develop, implement, and continuously improve the Quality Management System.
Manage the development of quality assurance staff, including coaching and development recommendations through performance reviews.
Manage the daily operation of the quality assurance unit, including maintenance of an effective system for completion of day-to-day work assignments, indexing of quality assurance records and oversight of the regulatory training program.
Manage/assist with the evaluation of overall compliance of the EPL Archives facility with applicable standard operating procedures (SOPs) and regulatory requirements through internal facility and process focused inspections.
Ensure proper distribution of findings to Archives Management personnel and staff for resolution, including initiation of SOP changes based on inspection findings.
Develop/coordinate changes to SOP’s, controls, and procedures sufficient to successfully satisfy any audit or other regulatory review performed by FDA, EPA, and other agencies with significant authority to conclude on the business operating compliance with complex regulations.
Manage/provide oversight for Corrective Action Investigations.
Lead and coordinate regulatory/client/facility audit response and SOP Updates between EU/US sites, ensuring continuity of procedures between sites.
Provide oversight for the maintenance of all inspection activity records; identify, document and report deviations from applicable regulations and standard operating procedures to Archives Management; ensure appropriate corrective actions have been completed.
Provide oversight for the collection and distribution of periodic reports to Archives Management which summarize deviation trending, client complaints and corrective action investigations status.
Develop and manage Vendor Assessment Program, including the scheduling/conducting of critical vendors/supplier assessments for suitability of use, distribution of findings to Archives Management personnel and vendors for resolution.
Serve as QA lead for client inspections and perform associated duties (e.g., agendas, summary reports, and follow-up to ensure resolution of findings).
Primary point of contact with responsibility to manage regulatory inspections and perform associated duties (e.g., daily summary reports, copying of materials).
Participate as a subject matter expert of the Management Technology Board.
Provide oversight/assist in the development of testing for associate compliance and working understanding of regulatory requirements.
Research and attend seminars and/or courses necessary to develop growth in the Quality Assurance field.
Participate and, when able, exhibit at quality assurance conferences to share and learn best practices within the quality assurance industry.
Research and communicate to internal management current trends in quality assurance areas and emerging topics of focus impacting QA practices.
Take part in company planning activities and/or committee assignments.
Review Non-Disclosure Agreements and Quality Agreements in conjunction with legal team to support business needs.
Develop, monitor, and manage approved department budget.