The Site Compliance Manager combines expertise in operations, training, and regulatory oversight to oversee regulatory compliance within our facility. This role ensures adherence to industry regulations, company policies, and safety standards while fostering a culture of continuous improvement and risk mitigation
Key Responsibilities: Compliance Responsibilities
- Assist the General Manager with facility management to ensure cGMP and OSHA compliance.
- Provide oversight of incoming pharmaceutical products to ensure all H&S and handling requirements are met.
- Manage the maintenance, repair, and operations of facility including infrastructure, equipment, and utilities providing facility vendor oversight as required.
- Oversee paperwork archiving to ensure compliance with regulatory and operational requirements.
- Assist the General Manage and Quality Director with managing facility-related emergencies and implement contingency plans.
- Assist the General Manager and Head of Procurement with monitoring facility budgets, optimizing costs ,and managing procurement of supplies and services.
- Assist with the filing of state and federal registration applications, permits, and/or declarations and ensure active registrations are held and maintained.
- Maintain oversight of the import, export, storage, handling, and control of Controlled Substances under DEA regulations by interpreting guidelines and ensuring internal procedures are up to date.
- Provide support to other Client departments to ensure alignment and compliance with internal SOPs, all applicable state/federal/global regulations, and support continuous training.
Training and Process Improvement Responsibilities
- Assess compliance risks in current Client processes and help develop more robust internal SOPs and training.
- Evaluate and assess training needs in collaboration with leadership and assist with the coordination and documentation of inter-department (cross) training, as needed.
- Create and deliver training programs, including classroom and digital formats, ensuring that training materials are engaging, organized, and effective.
- Develop educational resources (e.g., modules, videos, tests, and mock scenarios) and ensure that all training is documented according to company processes.
- Continuously assess and improve training content based on feedback and effectiveness.
- Support new employee onboarding to build understanding of compliance and training requirements.
Competencies, Traits, and Skills: - Ability to apply professional knowledge and understanding of applicable regulations/company SOPs to facilitate compliant operations for all pharmaceutical products in Client custody.
- Capability to lead communication between Client team members, clients, vendors, regulatory bodies, etc. to ensure timely delivery of project information, production records, registration renewals/updates, etc.
- Composure to liaise with client/regulatory representatives to plan and host facility visits or audits.
- Understanding of basic computer software (e.g., Microsoft Office) and ability to learn/utilize business critical applications.
- Strong organizational skills/multitasking abilities to support multiple Client projects concurrently and meet communicated deadlines.
- Strong interpersonal skills and the ability to manage, motivate, influence, and conduct compliant work behaviors in self and others.
- High level of independence and initiative, and an aptitude for attention to details, investigation, analysis, and problem solving.
Qualifications: - Bachelor's degree or equivalent in life science, law, or other applicable degree.
- 4+ years' pharmaceutical manufacturing, laboratory, or medical device experience, with knowledge of controlled substance and FDA/DEA regulations.
- 2+ years' clinical trials supplies experience.
- 2+ years' of project management or process improvement experience, Six Sigma experience a plus.
- Familiarity with GxP requirements and industry best practices.
