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Global Data Integrity Manager/Sr. Manager - Redmond, United States - Just Evotec Biologics
Description
Global Data Integrity Manager/Sr. Manager - Quality Systems | Remote (Job ID
Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics.
In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products.
The ideal candidate will have significant experience in leadingGlobal
Quality Systems (QS)
activities related to
Data Integrity (DI)
for the manufacturing of biological products from Phase 1 to PPQ to commercial.
Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.
Responsibilities:
Leads and directs all aspects of the QS related to DI functions at Global level to assure compliance with quality and industry regulatory requirements.
Collaborates with other GxP business process owners (BPOs) and Subject Matter Experts (SMEs) to review written procedures to create DI process structure and enhance training program.
Leads and participates in the development and deployment of DI process tools.
Develops, communicates, and delivers training regarding process or system changes.
Supports internal and external client audits and regulatory inspections. Including but not limited to SME for DI and related document retrieval during regulatory inspections.
Performs routine and ad hoc metric reporting and analysis for the Global and sites data related to DI process.
Provides communication as to the status of deliverables to customers, management, and stakeholders.
Educational Requirements:
Bachelor's degree in biological or engineering science with 8+ years relevant Quality experience and 10+ years' experience in industry.
Preferred Qualifications:
Experience in QS specifically DI processes, tools, concepts, and methodologies
Critical thinker with a comprehensive understanding of biologics 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.
Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making.
The base pay range for this position at commencement of employment is expected to be $110,000 to $150,000; Base salary offered may vary depending on 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.
Interested in this exciting opportunity?Please upload your up-to-date CV and a cover letter on our Workday platform. For inquiries, Reach out Sarah Lomas, Evotec Senior Talent Acquisition Specialist.
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.
Candidates must have the right to work in the country. All roles will be subject to a security screening check.Candidates must have the right to work in the country. All roles will be subject to a security screening check.
Note:
We may close this vacancy at any time once we find our perfect match.
Join us and be a part of the Just – Evotec Biologics team
#justevotecbiologics #evotecjobs #researchneverstops
#beCUREious #USAjobs #hybridjobs #seniormanager #manager #globaldataintegrity #globalqqualitysystems
Job Type:
Full-time
Pay:
$110, $150,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Schedule:
Monday to Friday
Supplemental pay types:
Bonus opportunities
Application Question(s):
Experience in QS specifically DI processes, tools, concepts, and methodologies
Must have Bachelor's degree in biological or engineering science with 8+ years relevant Quality experience and 10+ years' experience in industry.
Must have strong computer skills including Microsoft Office and eQMS databases.
Must have excellent interpersonal skills to collaborate with team members globally.
This is a field base role must be able to travel West Coast and East Coast to our sites.
Ability to Commute:
Redmond, WA Preferred)
Ability to Relocate:
Redmond, WA 98053:
Relocate before starting work (Required)
Work Location:
Hybrid remote in Redmond, WA 98053
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