Document Control Manager (Remote w/ travel)

Job Title: Document Control Manager

Job Number: 33973

Location: Remote, 

Job Description

Responsibilities

We are seeking a Document Control Manager who will oversee and manage document control activities related to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP). The successful candidate will have experience with Veeva Systems and will play a critical role in ensuring that Apogee maintains the highest standards of document management and regulatory compliance. This position will report to the Head of Quality Assurance.

Required Skills

Key Responsibilities

1. Document Control Management:
   • Develop, implement, and maintain document control policies, procedures, and systems in accordance with GXP regulations
   • Utilize Veeva Systems to establish and manage a centralized electronic document management system (EDMS) for GXP documentation and employee training
   • Ensure proper classification, indexing, version control, and archiving of GXP-related documents
2. Regulatory Compliance:
   • Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH)
   • Oversee the complete document lifecycle, including creation, review, approval, distribution, training, retrieval, and obsolescence to ensure full compliance
3. Quality Assurance:
   • Implement and maintain robust quality control measures for GXP documents
   • Conduct regular audits of GXP documents and processes to identify and address discrepancies or non-compliance issues
   • Lead the CAPA process related to GXP documentation
4. Veeva Expertise:
   • Leverage experience with Veeva Systems to optimize document management processes, training, and workflows
   • Provide guidance and training to staff on using Veeva for document control and compliance purposes
5. Cross-functional Collaboration:
   • Collaborate closely with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance
   • Work in partnership with subject matter experts to collect and update GXP-related information
6. Continuous Improvement:
   • Identify opportunities for process improvements in GXP document control practices
   • Implement technological solutions and enhancements, leveraging Veeva, to streamline GXP document management and compliance
7. Risk Management:
   • Identify and mitigate risks associated with GXP document control processes
   • Develop contingency plans for document retrieval and recovery in case of system failures or emergencies

 
Ideal Candidate

• Bachelor's degree or higher in a relevant field (e.g., biology, chemistry, pharmaceutical sciences).
• Substantial experience (4+ years) in document control or quality assurance within the biotechnology or pharmaceutical industry, with a strong focus on GXP regulations
• Proficiency in utilizing Veeva Systems for document management, training, and compliance
• Thorough knowledge of GXP regulatory requirements and quality standards
• Exceptional organizational, communication, and problem-solving skills
• Attention to detail and a commitment to maintaining accuracy and compliance
• Ability to work in a fast-paced and nimble environment with a rapidly growing organization
• Strong leadership skills and the ability to collaborate and work effectively with cross-functional teams
• Familiarity with Computer System Validation (CSV) processes related to GXP document control and training systems
• Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
• Ability and willingness to travel up to 15% (approximately 8 times per year for company meetings)

 
What We Offer 

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless. To learn more about our C.O.R.E. values and how they manifest day-to-day, [Please click the Apply button for the link or email]
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO 
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• 100% remote with regular all team, in-person meetings to build relationships and problem solve