Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
The Manager of Regulatory Affairs and Quality Assurance Department is responsible for providing regulatory and quality assurance leadership and guidance throughout Eurofins CellTx laboratory. Manager is responsible for day-to-day operational implementation of activities for Quality Assurance and Regulatory Compliance. Responsibilities include the management of quality system activities, to include but may not be limited to: Quality Event Management, Change Management, Risk Management, Audits (both internal and external) quality planning and improvement, quality monitoring and reporting, and quality system training to promote the company and department in achieving its goals. Responsibilities also include Regulatory-related activities such as management and oversight of regulatory filings and submissions. This position works closely and collaboratively with the other functional areas throughout the laboratory.
Regulatory Affairs / Quality Assurance Manager responsibilities include, but are not limited to, the following:
QUALITY ASSURANCE OVERSIGHT
- Manages personnel activities within the RA/QA department (e.g., timecards, time off); collaborate with Vice President in employee performance evaluations.
- Hires, coaches, reviews, manages and terminates staff. Sets goals for employees.
- Counsels RA/QA staff with regard to problems / issues encountered in daily activities.
- Identifies continuous improvement opportunities and coordinate actions) to improve processes; proactively manage critical issues of a quality nature.
- Contributes, manages, and executes effective, proactive quality and regulatory strategies and plans.
- Creates and maintains relationships with other managers within the Eurofins CellTx laboratory that is productive and promotes teamwork and change.
- Set and oversee the annual schedule of internal quality and externally hosted audits.
- Host and guide quality audits from clients and other external regulatory agencies.
- Report on and drive timely corrective actions from both internal and external audit findings
- Conduct timely investigations in coordination with Quality Assurance related to site quality events, including, but not limited to customer complaints, inquiries, non-conformances, corrective actions, and audit findings.
- Respond to client and other external regulatory agencies to provide supporting information as needed
- Oversee quality activities by ensuring quality system training
- Provide oversight on quality management system activities, such as corrective and preventative actions, internal & external assessments, document & records management, etc.
- Manage the regulatory aspects of promotional materials.
- Ensure timely and accurate regulatory filings and submissions
- Be accountable to the achievement of departmental goals and initiatives
- Lead and manage a high performing regulatory department capable of supporting multiple internal and client projects.
- Develop, implement and maintain regulatory SOP's
- Maintain annual licenses, registrations and submit updates for required regulatory submissions.
- Proactively manage critical issues, taking leadership for the regulatory contribution
- Reports critical information to Laboratory Directors and Executive Team, as needed
- Identifies continuous improvement opportunities and take action to improve processes and metrics for current performance
- Performs duties in compliance with all applicable regulatory and accrediting agencies and cGMP expectations, including but not limited to: Facility and equipment maintenance, validation review and approval, training (internal, continuing education, proficiency testing, annual GMP, etc.)
- Consultations on quality related questions and issues from internal and external clients.
- Supports the company and department in meeting its goals and initiatives.
- Identifies, coordinates and/or implements tools and process improvements to promote efficiency and process improvements throughout the organization.
- Serves as a liaison for the organization to outside vendors and clients.
- Assists in the development of a budget and monitors RA/QA department expenditures.
- Performs duties in compliance with all applicable regulatory and accrediting agencies.
- Facilitates the management and effectiveness of the document control and corporate training programs.
- Supports the Vice President in:
- executing organizational and department initiatives.
- Preparing materials as requested by Executive Management (trending data, Management Review, customer-specific meetings).
- Other duties as assigned.
REGULATORY AFFAIRS OVERSIGHT
- Provides perspective and Subject Matter Expertise on the interpretation of Clinical Laboratory Regulatory requirements that impact the Company's operations and regulatory compliance.
- Provide Quality Management support for QMS-related activities across our network of laboratories.
- Assists in designing and developing overall corporate quality system.
- Establishes, monitors and/or modifies quality metrics to monitor the performance and state of control of the QMS; assist in dissemination of quality monitoring activities.
- Creates and revises quality and regulatory related SOPs to ensure compliance with applicable regulatory authorities.
- Reviews and approves quality event investigations (including corrective action plans) to ensure thorough and high-quality records.
- Maintain a strong working knowledge of applicable regulatory guidelines for agencies including, but not limited to, FDA, CLIA, ISO 15189, and state agencies such as New York.
- Promote and ensure regulatory inspection readiness activities.
- Hosts and guides quality audits and inspections from clients and other external regulatory agencies; supports client and regulatory audits/inspections in a remote capacity, when necessary.
- Compiles and /or reviews client and Regulatory audit responses to ensure our commitments. meet quality and regulatory expectations; drives timely corrective actions for those findings.
- Verifies the accuracy and current state of licenses, registrations, and other regulatory submissions; assist in performing those submissions, as needed.
- Identifies Quality System-related training needs; facilitates the delivery of that training.
QualificationsBasic Minimum Educational Qualifications:
- Supports Eurofins CellTx's business philosophy, leadership values and ethics.
- In order to meet Eurofins CellTx's quality policy and objectives, all employees are expected to meet basic expectations of Eurofins CellTx's quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.
- As a partner to the Operations team, defines the best tactical direction for Quality Management. initiatives & ensures compliance and alignment to company mission, values, and business goals.
- Be a team player, develop and maintain excellent working relations within the organization.
- Demonstrates a high level of team management and empowerment and possess the ability to perform to the requirements.
- Enthusiastic, self-motivated person with great communication skills who can support regulatory compliance and quality management for the company.
- Demonstrates a high level of team management and empowerment and possess the ability to perform to the requirements.
Basic Minimum Qualifications:
- Bachelor's Degree in a Science-related field; advanced degree preferred.
Potential Environmental Factors:
- A minimum of 5 years of quality experience within the clinical laboratory industry.
- A minimum 3 years of technical laboratory experience in a regulated environment is also preferred.
- A minimum of 5 years of experience with regulatory and/or accrediting agencies (e.g., FDA, ISO, CLIA) hosting/performing inspections, responses to regulators, etc.
- Quality certification highly desired (e.g., ASQ-CQA, ASQ-CQM/OE).
- Technical knowledge of regulatory requirements, including but not limited to FDA, CLIA, ISO.
- Ability to interpret and apply government and industry regulations.
- Experience in the preparation and filing of regulatory submissions for Clinical laboratory operations.
- Ability to analyze, define and effectively convey difficult and complex issues in a way that accurately communicates the issues to leadership and external business partners.
- Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills.
- High level of initiative and excellent collaboration skills to facilitate cross-functional projects.
- Ability to problem solve and make decisions on complex issues, often in a cross-functional team setting.
- Strong organizational and planning skills as well as strong attention to detail.
- Ability to work independently with limited supervision, adapt to change and manager multiple tasks.
- Strong skill in the Microsoft Office Suite and working knowledge of electronic publishing/file management
- Project a positive, professional demeanor at all times.
- This position will require minimal travel within the US.
- Authorization to work in the United States indefinitely without restriction or sponsorship
- This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins CellTx's Safety and Exposure procedures. This includes using the provided safety clothing and equipment.
- For a list of potential chemical hazards, see appropriate SDS sheet.
Position is full-time, Monday - Friday 9:00 am - 5:30 pm,withovertime as needed. Candidates currently living within a commutable distance of Tucson, AZ are encouraged to apply.
- Salary Range $86,000 - $122,000
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Please be aware that this role will require access to a site that requires COVID-19 vaccination or exemption from vaccination requirements. Prior to starting work in this position, employees must show proof of full Covid-19 vaccination or exemption from vaccination requirements. Exemptions will be granted as warranted by medical contraindications, disability or sincerely held religious beliefs.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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