Sr. Manager, Global Document Control and Records Management

4 weeks ago


West Coast of the United States Just-Evotec Biologics Inc. Full time

Sr. Manager, Global Document Control and Records Management - Just Evotec Biologics (Field Based)

Just-Evotec Biologics (JEB) is seeking a highly motivated Sr. Manager Global Document Control and Records Management. This position leads all Global Document Control and Records Management activities related to the manufacturing of biological products from Phase 1 to commercial.

Note; Travelling to other JEB sites as required.

Responsibilities

Leads and directs all aspects of the Document Control and Records Management functions at Global level to assure compliance with quality and industry regulatory requirements.

Collaborates with GxP business process owners (BPOs) and Subject Matter Experts (SMEs) to review written procedures in order to create document management structure and enhance training program

Owns the Global Document Control and Records Management business process.

Ensures that the site-specific document control processes and procedures comply with the Global processes.

Leads and participates in the development and deployment of document control tools.

Develops and delivers training regarding process or system changes.

Supports internal and external client audits and regulatory inspections. Including but not limited to SME for document control and document retrieval during regulatory inspections.

Performs routine and ad hoc metric reporting and analysis for the Global and sites data related to Document Control and Records Management.

Provides communication as to the status of deliverables to customers, management and stakeholders.

Responsible for managing the Document Control team, including recruitment and performance management.

Qualifications

Bachelor’s degree in biological or engineering science with 8+ years of relevant Quality experience and 10+ years’ experience in the biotech industry.

Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company.

Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.

Expertise in tools, concepts, and methodologies of QA.

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; and building teams.

The base pay range for this position at commencement of employment is expected to be $135,000 to $160,000; 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.


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