Quality & HSE Manager

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Job description

Overview:
Repligen has a firm commitment to continually improve our Quality Management System, adhere to all Regulatory and Statutory Guidelines with a clear focus to meet or exceed all of our Customer requirements.

The Quality and HSE Manager is responsible for the QMS compliance ensuring that all our Products and Services exceed Customer expectations, also for overseeing the quality assurance and compliance with health, safety, and environmental standards within an organization.

You will report to Associate Director, Operations and be based in Estonia.

Responsibilities:
As Quality and HSE Manager you will be responsible for the following:

Lead the local Quality team and actively participate and represent Estonian Operations in the Global Quality team.

Maintain compliance to ISO 9001:2015 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, Deviations, CAPA, Validation.

Monitor and continuously develop Supplier Quality related activities e.g. Incoming Inspection and Supplier Evaluation.

Develop and monitor the Quality KPI-s both at global and local level.

Maintain internal and external (customer and vendor) audit schedules, develop and mentor auditor teams.

Create/revise procedures/practices and specifications, and provide training on quality systems and procedures.

Represent Quality function for all Product and Process Change Controls.

Support information flow between different QMS-es in Repligen Corporation (e.g. After-Sales Service activities)

Drive EHS related activities and represent Estonian site in corporate initiatives.

Support with Environmental Management

Manage equipment, resources and budgets efficiently.

Qualifications:
The successful Quality and HSE Manager will meet the following requirements:

Bachelor's degree in Engineering or similar field is required.

Minimum 5 years of experience in Quality Management (ISO9001, ISO14001, ISO45001) activities.

Demonstrated process knowledge in supplier quality development, quality control, documentation management.

ERP usage experience and experience with LEAN implementation is strongly preferred.

Experience in managing people and willingness to be a role model.

Strong attention to detail and good communication and problem solving skills.

Very good Estonian & English language skills.

Ability to work occasionally outside normal office hours due to differing time zones within the company.

Ability to travel mainly in Europe & the US.

What Repligen Offers:
Repligen offers you a competitive remuneration package, including a yearly bonus, additional health insurance package, sport benefits and flexible working hours. But most importantly Repligen offers you a stimulating, fast-paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team and a modern office in Jüri, Estonia.

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