Manager, Document Management, Analytical Development & Quality Control

The Opportunity:

As a manager of document management, you will be responsible for overseeing the lifecycle of controlled documents. This role ensures compliance with regulatory requirements, company quality standards, and effective document control practices across internal and external stakeholders. We are looking for a detail-oriented and proactive individual with a strong background in pharmaceutical or biotech industries. This position develops strategic plans related to change control, other ADQC documents, and the implementation of robust corrective actions to support Analytical Development and Quality Control by applying function expertise.

• Manage the creation, review, approval, issuance, and archival of controlled documents, including SOPs, work instructions, and documents initiated at contract organizations.

• Develop and implement effective document management including change control processes and procedures to ensure compliance with regulatory requirements and industry best practices.

• Collaborate with cross-functional teams to evaluate, prioritize, and manage change requests.

• Ensure proper tracking, documentation, and closure of change controls, including impact assessment, change action executions, and required approvals.

• Communicate changes and their impact to relevant stakeholders, including senior management, quality assurance, regulatory affairs and contract organizations.

• Coordinate and/or lead cross-functional meetings with multiple departments to maintain accurate and up-to-date documentation.

• Monitor and track document metrics to identify trends, gaps, and areas for improvement.

• Continuously evaluate and improve document management to increase efficiency and effectiveness.

• Act as a subject matter expert for document management related matters and provide guidance and support to colleagues across the organization.

• Manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.

• Foster a culture of quality and compliance within the organization through proactive communication and collaboration with all departments.

Required Skills, Experience and Education:

• BS in Life Science, Chemistry, Pharmaceutical Science or related discipline.

• 6+ years in document control or relevant experience within pharmaceutical or biotech industry.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

• Have a strong attention to detail.

• Stay current with industry regulations and guidelines related to controlled documents and make recommendations for process improvements as needed. 

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