Site Compliance Manager (Bastrop, TX)
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.
- 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.
- 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.
- 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.
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