Site Compliance Manager
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.
- 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.
Recommended Jobs
Full Time Anesthesia Job Brownsville, TX
Leadership. Balance. Opportunity. Its All Here at NorthStar. Join NorthStar Anesthesia as we continue our exciting nationwide expansion! Were seeking passionate anesthesiologists to help deliver ex…
Distribution Technicians - C Shift
Job Description Job Description Company Description Avery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company. We are Making Possible™…
Regional Dental Manager
Join URBN Dental – A People-First Culture Recognized for Excellence! Are you a people-focused dental leader who thrives on multi-site operations, mentorship, and impact? Do you lead with empathy, s…
Stocktaker - Administrative
Position Title: Stocktaker Department: Inventory Control Supervisor: Inventory Controller FLSA: Non-exempt Position Summary: The Stocktaker is responsible for ensuring all products i…
Pediatric Outpatient Occupational Therapist-OT - JO-2507-39927
Job Description Job Description SIGN ON BONUS! We are seeking an Occupational Therapist near San Marcos, TX! This multi-clinic practice is in need of an Occupational Therapist who takes a collabo…
CT Tech
TOP HOUSTON HEALTH SYSTEM SEEKING CT TECHNOLOGIST full time, permanent position extremely competitive pay excellent benefits sign on bonus ARRT (CT) required cost of living below nation"s average n…
Assistant Store Manager
Job Description Job Description Furniture, essential to everyday life but often in hidden plain sight. At Nadeau, our furniture comes with a soul! Well not quite literally. Our mission is to c…
Team Lead - Moving/Hauling Service
Position: Mover Team Member Are you ready to grow yourself personally and professionally? Join our team! Up To $25.00/hour. As a Team Lead for College HUNKS Hauling Junk and College HUNKS Movin…
Emergency Medicine Physician in Graham, Texas
TeamHealth has an excellent opportunity for an emergency medicine physician to join our emergency department (ED) team at Graham Regional Medical Center in Graham, Texas. Graham Regional Medical Cent…
Cook
Job Description Job Description Overview Role: Cook Join Healthcare Services Group (HCSG) as a Cook, where you will play a vital role in preparing and cooking nutritious meals for resid…