Eurofins DiscoverX is a leader in providing solutions and support to the pharmaceutical industry by developing, manufacturing, and commercializing reagents, cell-based assay kits,, and profiling and screening services. The BioMAP division of Eurofins DiscoverX supports the BioMAP platform, an innovative, powerful in vitro phenotypic profiling platform that provides translational biology support for clients' drug discovery programs.
Quality Assurance Manager Responsibilities include, but are not limited to, the following:
Leads the quality and regulatory initiative for the company to comply with FDA GxP Regulations, EMEA and OECD as applicable
Manages the Quality Management System for the entire business operation
Reviews and/or approves deviations, OOS's, CAPAs, change control in an efficient manner for adequate and timely closeout of these events
Supports the implantation of departmental procedures (SOPs) to ensure compliance with applicable regulatory requirements
Aligns vision and direction of group through key leadership initiatives
Provides excellent customer service focus and communication with clients
Leads as a positive initiator of change and improvement in operational and quality processes
Develops positive engagement with others
Works autonomously to deliver on KPI and objectives communicated by General Manager
Collaborates with other managerial personnel in formulating, establishing, and maintaining the company quality policies and standard operating procedures.
Engages directly during on site investigations/audits in order to mitigate any quality-related issues.
Represents the company in regulatory and quality in external regulatory agencies and conferences
Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Quality System activities (including but not limited to Internal Audit, CAPA, Change Control, Deviations, Supplier Approval)
Serves on various internal committees (e.g., computer validation, SOP review, etc.) to provide a QA perspective.
Works with operations and scientific staff to provide quality and regulatory guidance for clients' projects to enhance client satisfaction.
Oversees organizational facilities management by ensuring that a system of archiving facilities documents and project study files is in place and is secure as expected by pertinent regulatory requirements.
Reviews pertinent publications to stay abreast of the regulatory and quality developments within the industry
Owns the accountability and responsibility to delivering to client needs and timelines.
Adheres to site employee health and safety (EHS) requirements
Demonstrates and promotes the company vision
Regular attendance and punctuality
Applies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position.
Provides cross-functional support to other departments as required.
Adjusts work hours as needed to meet client deadlines
Works in a laboratory setting, meeting the physical requirements of laboratory experiments.
Performs other duties as assigned
Achieves/exceeds assigned sales targets for the assigned geographic territory.
The ideal candidate would possess:
Previous experience in a chemistry and/or biological laboratory preferred.
Ability to align vision and direction of group through key leadership initiatives
Ability to focus on multiple projects in conjunction with other priorities
Demonstrated ability to lead a QAU in order to ensure regulatory compliance in the work performed at the site.
Ability to collaborate with non-quality colleagues in order to meet business objectives without compromising regulatory compliance.
Ability to advise senior management in quality related matters to the business (i.e. GxP regulatory risks, other).
Internal and external auditing experience from clients and regulatory agencies
Previous experience managing/hosting client audits and regulatory inspections.
Graduate degree in business is desirable
Experience with specific quality systems in the pharmaceutical, biotechnology industry and/or med devices
Desire to take areas of personal development and turn them into areas of future strength to Ability to influence change in work behaviors and culture change
Experience managing a departmental/team budget help the business.
Ability to travel (usually less than 25%) when needed
Lean certification preferred
Previous experience working at a CRO or CMO.
Basic Minimum Qualifications:
Bachelor's degree or advanced degree in a chemical or biological science related field from a four-year college or university.
Minimum of 5 years in Quality/Regulatory,
Strong knowledge and experience of GxP quality systems
Proven demonstration of developing positive engagement with others
Proven demonstration of project management and successful and timely completion
Proven demonstration of attention to detail as a key contributor to operational excellence
Authorization to work in the United States indefinitely without restriction or sponsorship