Manager​/Senior Manager Quality Assurance

Company Description

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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.

In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

The Manager/Senior Manager Quality Assurance is primarily responsible for overseeing the day-to-day operations of the Quality Assurance team. Performs activities of high level, variety, and complexity to ensure quality and compliance with applicable Federal and State regulatory requirements and guidance documents, including document review, audits, inspections, consulting on quality and compliance issues, training, and trend analysis. Works with Operations to ensure client needs are consistently met.

Leads various teams to ensure quality system is continuously improved.

Essential

Job Duties:

Manager - Minimum

* Oversee daily operations and provide overall direction and assistance to associates; work with leadership to ensure appropriate staffing of area of responsibility; review/approve associate time sheets

* Interview and select candidates for open positions when needed

* Assess team members by conducting effective performance reviews, and coach associates through necessary performance improvements; onboard as needed

* Host and guide quality audits from clients and external regulatory agencies

* Participate in creation/revision of SOPs for the department as required and ensure policies and procedures are monitored and updated to include regulatory changes

* Communicate with internal clients on open audits, review deviations, investigations and CAPAs

* Provide support as needed on quality management system activities, such as corrective and preventative actions, internal & external assessments, document & records management, ensuring data integrity, etc.

* Support development of system and process improvements that would enhance compliance to requirements

* Identify inefficiencies in processes, workflow, and throughput and implement process improvements to minimize waste

* Accept, complete, and report on special assignments within the agreed upon timeframe

* Work with laboratory operations directors, managers, and supervisors to develop and maintain lists of schedules for responsible tasks

* Maintains accurate quality assurance files, records, and databases, and may perform analysis and trending

* Provides consultation on complex quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed

* Provides training in routine and complex quality and compliance topics for Quality Assurance group and/or other inter-company departments

* Ensure Quality associates have thorough understanding of expected outcomes, troubleshooting, and data analyses by serving as mentor and coach

* Ensure Quality associates are always up to date with training and competency assessments for their areas of responsibility

* Monitor department productivity and ensure appropriate quality metrics are met

* Resolve problems and ensure that appropriate corrective and preventive actions are taken when deficiencies or errors are found ensuring routing and escalation to department supervisors/manager

* Demonstrates strong client service skills, teamwork, and collaboration

* Adhere to all quality and safety standards, as well as ensuring compliance with all applicable regulatory agencies

* Adhere to policies and protocols in the laboratory; understand and demonstrate proficiency with quality monitoring activities such as quality indicators and quality reporting related to equipment and monitoring such as KPIs for Quality Meeting

* Participate in data reporting,…