Biotech Compliance & Stewardship Lead is a critical role that enables safe, compliant, and efficient research operations. As the primary CAMS representative for the Biotechnology organization, this role ensures alignment with regulatory requirements, internal standards, and global governance expectations.
This role provides compliance oversight and leads audit and inspection management for work involving both regulated and non-regulated biotech materials. It oversees global training and documentation, leads compliance gap analyses to ensure alignment with permit and business requirements, and maintains continuous inspection readiness to mitigate risks to freedom to operate (FTO) at both site and enterprise levels.
The Lead drives root cause analyses and corrective actions to address audit and inspection findings, proactively identifies and mitigates risks that could impact ISO certification, and leads Business Continuity and Disaster Recovery efforts to ensure organizational readiness and resilience.
Through cross-functional collaboration, this individual drives clear communication, training, and continuous improvement of quality management system processes to enhance operational effectiveness, strengthen audit readiness, and promote proactive risk management and compliance across the Biotechnology R&D sub-function.
What You’ll Do:
- Represent the Biotechnology sub-function as a member of the CAMS R&D Governance team.
- Drive clear and consistent communication of CAMS information, updates, changes, best practices, and audit data/metrics to Biotechnology employees, leaders, and key stakeholders.
- Promote and champion the use of management system principles and tools to enhance operational effectiveness, customer satisfaction, measurement, and continuous improvement across Biotechnology.
- Ensure CAMS processes within Biotechnology remain aligned, integrated, and effectively maintained, while proactively identifying opportunities to strengthen execution and compliance.
- Improve operational efficiency and effectiveness by developing cross-functional processes and identifying opportunities for collaboration.
- Coach and support process owners, document controllers, training controllers, and other CAMS support roles to maintain strong understanding and execution of the management system.
- Deliver CAMS onboarding training to new employees to ensure understanding of role-specific requirements and expectations.
- Facilitate training on CAMS tools and systems, including EQuIPT and ETQ Reliance to support effective use and adoption.
- Apply management system principles and methodologies to mitigate organizational risk and support compliance.
- Identify process and management system gaps and drive corrective and improvement actions to prevent recurrence.
- Partner with Quality Monitoring and Auditing teams to inform audit plans, including scope, timing, and agendas, based on organizational risk.
- Prepare and coach Biotechnology teams to ensure strong process understanding and management system effectiveness before, during, and after audits.
- Partner with Biotechnology teams to maintain accurate seed and material inventories and permits in alignment with company policies.
- Collaborate with Biotech Safety and Lab Operations Leads to identify nonconformities, address compliance gaps, and drive continuous improvement at the intersection of compliance, safety, and operations.
What You Need:
- Bachelor’s degree in biology, chemistry, agronomy or related field or 5+ years working in a related field.
- Safety first mindset.
- Strong attention to detail, including ability to write/edit procedures and compliance policies.
- Knowledge of seed inventory and permitting requirements and systems or a desire and ability to quickly learn about these requirements.
- Demonstrated ability to independently lead projects while effectively collaborating with cross-functional teams.
- Excellent interpersonal and communication skills, including the ability to lead meetings, deliver engaging presentations, and collaborate effectively with cross-functional teams and senior leadership.
- Ability to influence and lead across teams without direct authority.
- Demonstrated willingness to expand skills and take on additional operational responsibilities as opportunities arise.
What Makes You Stand Out:
- 2-5 years of experience working with management systems and/or compliance-related processes.
- Knowledge of Excellence Through Stewardship (ETS) requirements.
- ISO 9001:2015 certification and/or knowledge of quality management system principles.
** Please note there is no relocation or visa sponsorship available for this position.
Benefits – How We’ll Support You:
Numerous development opportunities offered to build your skills
Be part of a company with a higher purpose and contribute to making the world a better place
Health benefits for you and your family on your first day of employment
Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays
Excellent parental leave which includes a minimum of 16 weeks for mother and father
Future planning with our competitive retirement savings plan and tuition reimbursement program
Learn more about our total rewards package here -
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Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team.