Senior Manager, Global Quality Management System (GQMS) - Redmond, WA
The Senior Manager, Global Quality Management Systems (GQMS), reporting to the Senior Director of Quality Management, will serve as the process owner for key quality systems, including but not limited to Deviations/Investigations, CAPA, and Supplier Quality. Additionally, the Senior Manager will provide support to other Quality Management System (QMS) Business Process Owners (BPOs). The ideal candidate will have experience in configuring and deploying eQMS technologies and tools.
Note: Would be open to remote working for the right candidate. Will be visiting sites in Washington and Toulouse site, once a quarter.
Responsibilities
- Leads and directs all aspects of the assigned Quality System(s) at a Global level to assure compliance with global regulatory requirements and industry best practices.
- Serve as BPO and Subject Matter Expert (SME) for the assigned Quality System(s), including the deployment and updates to related electronic systems and tools.
- Develop (in collaboration with other BPOs and SMEs), and maintain controlled documents (SOPs, work instructions, job aids, training materials, etc.) related to the execution of the assigned Quality System
- Develop (in collaboration with other BPOs and SMEs), maintain and deliver training materials related to correct and compliant execution of the quality system processes as well as system or process changes.
- Supports internal audits, client audits and regulatory agency inspections, including the development of responses and corrective actions to observations.
- Ensure and communicate status of deliverables to clients, JEB management, and stakeholders.
- Monitors and reports system performance metrics at the global level. Supports sites in ensuring that site metrics comply with the global standard.
- Conduct periodic reviews of this quality system and ensure its continuous improvement.
- Other related responsibilities as assigned by management.
Qualifications
- Bachelor’s degree with 8+ years of relevant Quality experience and 10+ years’ experience in the biotech industry.
- Experience in Quality Systems Management processes, tools, concepts, and methodologies.
- Critical thinker with a comprehensive understanding of biologics and pharmaceutical regulatory requirements, risk management principles, and science-based decision making.
- Project management experience.
- Excellent interpersonal skills to collaborate with team members globally.
- Strong computer skills including Microsoft Office and eQMS databases (experience with Veeva QualityDocs and eQMS a plus).
- Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making.
- Ability to travel to JEB sites as required
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
The base pay range for this position at commencement of employment is expected to be $111,360 to $152,425; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Top Skills
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
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