Document Control & Training Manager

Position Summary: 

Reporting to the Vice President of QA, the Manager of Document Control & Training will be responsible for document routing, tracking document review and approval process, assessing document related training requirements and tracking training. The Document Control & Training manager will ensure that document management and training programs are implemented and are effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets.  Additionally, this position should have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements. 

Key Responsibilities:

• Manage the routine document control and training operations, including (but not limited to) ensuring appropriate documents standards are developed and managed, workflows are processed, and documents archived appropriately, training requirements for GxP employees are identified and completed, and new hires are effectively onboarded.
• Own and manage the electronic systems supporting GxP documents and training needs, including (but not limited to) scaling business processes to match recent and future growth, developing and seeing through implementation of strategic plans and collaborating with stakeholders to ensure that current and future processes and systems meet user requirements.
• Maintain eDMS/LMS (Veeva) platforms in a validated state. 
• Manage document archive of product files, validation plans and reports, and production records. Ensure all document control processes and retention of records are compliant with applicable QMS standards. 
• Define the policies/procedures for document control processes and company training programs.
• Liaise with external operations and internal stakeholders regarding DC approvals.
• Training, Change Control, Deviation and CAPA metric reporting.
• Write and revise Document Control SOP’s.
• Train, motivate and guide staff and new hires on the Document Control process.
• Collaborate with Quality Assurance and operational teams to create training content for quality management, clinical and regulatory processes.

Requirements:

• Bachelor’s degree with minimum of 6 years of related experience in Pharmaceutical or other regulated industry
• Experience in a smaller pharma/biotech which has reached commercial stage is ideal.
• Familiar with quality management systems, document control systems and learning management systems.
• Previous experience in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)) quality guidelines and FDA regulations compliance including 21 CFR Part 11 / Annex 11.

Key Stakeholder Relationships:

• Collaborate with all levels of leaders to resolve document management and training issues.
• Manage in-process document management and training improvement initiatives including suggesting or evaluating change, as needed.
• Report metrics to Senior Leadership and Compliance to ensure the business is aware of any potential risks including all identified CAPA plans.

People Leadership:

• May supervise and or direct the work of outside workers, select site staff, and or professional consultants to deliver training, where needed.

Critical Skills:

• Experience building document management and training programs.
• Working knowledge of Federal Regulations and Guidance within healthcare industry.
• Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills, and team player.
• Excellent verbal and written communication skills.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
•  Ability to navigate and be successful in a fast-paced, highly matrixed work environment.

The anticipated salary range for the position of Manager, Document Control & Training based in our Menlo Park, CA office is $132,000-160,000.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc.  Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.