Summary

Evotec SE is a leading German drug discovery and development partnership company headquartered in Hamburg, Germany. Founded in 1993 by Nobel Laureate Manfred Eigen and other scientists, Evotec operates as a contract research organization (CRO) that collaborates with pharmaceutical companies, biotechs, academic institutions, and government agencies to advance therapeutic innovations. The company employs approximately 4,788 professionals worldwide and specializes in small molecule drug discovery across multiple therapeutic areas including oncology, neurological disorders, metabolic diseases, cardiovascular conditions, inflammation, pain, and respiratory diseases. Evotec's comprehensive service portfolio encompasses target identification and validation, hit identification, in vitro pharmacology, integrated CMC services, and proteomics. With facilities across Europe and the United States, the company has established long-term strategic alliances with major pharmaceutical partners including Bristol Myers Squibb, Bayer, Sanofi, Boehringer Ingelheim, and Eli Lilly. Evotec's innovative Pipeline Co-Creation model represents a flexible, multi-modality approach to drug development, leveraging data-driven disease understanding and AI technologies to accelerate the delivery of quality drug candidates.

Job description

What You'll Do

Assess and approve all quality events in eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
Provides communication as to the status of deliverables to customers, management, and stakeholders.
Deliver training for QMS process or system changes.
Provide QA QMS in supporting internal and external client audits and regulatory inspections.
Review and approve effectiveness checks for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement.
Execute process performance and product quality monitoring programs.
Identify potential compliance issues.
Alert senior management of significant quality, compliance, supply, or safety risks.

Who You Are

Experience in helping to maintain a Quality infrastructure in a fast-paced growing company.
Understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF).
Experience in release testing, stability testing, equipment qualification, and method qualification.
Experience in tools, concepts, and methodologies of QA.
Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES.
Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.
Bachelor's degree in biological or engineering science.
Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
Ability to collaborate and communicate cross-functionally.
Proven attention to detail.

Requirements

Bachelor's degree in biological or engineering science
Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
Understanding of biologics regulatory requirements, risk management principles, and science-based decision making
Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF)
Experience in release testing, stability testing, equipment qualification, and method qualification
Experience in tools, concepts, and methodologies of QA
Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams
Ability to collaborate and communicate cross-functionally
Proven attention to detail

Benefits

Medical, Dental & Vision
Short-term disability
Long-term disability
Company paid basic life insurance
401(k) company match
Flexible work
Generous paid time off
Paid holiday
Wellness benefits
Transportation benefits
Discretionary annual bonus

Company overview

Evotec SE is a leading German drug discovery and development partnership company headquartered in Hamburg, Germany. Founded in 1993 by Nobel Laureate Manfred Eigen and other scientists, Evotec operates as a contract research organization (CRO) that collaborates with pharmaceutical companies, biotechs, academic institutions, and government agencies to advance therapeutic innovations. The company employs approximately 4,788 professionals worldwide and specializes in small molecule drug discovery across multiple therapeutic areas including oncology, neurological disorders, metabolic diseases, cardiovascular conditions, inflammation, pain, and respiratory diseases. Evotec's comprehensive service portfolio encompasses target identification and validation, hit identification, in vitro pharmacology, integrated CMC services, and proteomics. With facilities across Europe and the United States, the company has established long-term strategic alliances with major pharmaceutical partners including Bristol Myers Squibb, Bayer, Sanofi, Boehringer Ingelheim, and Eli Lilly. Evotec's innovative Pipeline Co-Creation model represents a flexible, multi-modality approach to drug development, leveraging data-driven disease understanding and AI technologies to accelerate the delivery of quality drug candidates.