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SalaryManager/Sr. Manager, Global Data Integrity | Just. – Global Quality Systems | Remote
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 leading Global 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.
- As Business Process Owner (BPO) for DI owns the Global DI business process.
- 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.
- Ensures that the site-specific DI process and procedures comply with the Global process.
- 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.
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.
