Lead Compliance Officer

Stokes Pharmacy•Mount Laurel Township, NJ

3d•Onsite

About The Position

The Lead Compliance Officer within Epicur Pharma will report directly to the General Manager. This individual is responsible for ensuring operations are in alignment with the regulatory frameworks set forth by the Food and Drug Administration (FDA) and other applicable regulatory authorities. The Lead Compliance Officer acts as a key advisor and leader in ensuring the organization's adherence to ethical and legal standards, while also contributing to the overall effectiveness and efficiency of the business. This role is not just about adherence to standards; it's about leading with foresight, crafting and executing comprehensive compliance strategies that safeguard our commitment to quality and regulatory conformance in every facet of our Epicur’s operations.

Requirements

Minimum of 8 years of experience in pharmaceutical, analytical testing, and/or related science field
Minimum 3 years of experience in pharmaceutical compliance or quality assurance
Familiar with GxP, FDA, ICH, and OSHA requirements
Familiar with 21 CFR Part 11
Familiar with Microsoft Office applications (Word, Excel, etc.)
Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc.
Must have strong organizational skills and exceptional attention to detail
Must exhibit punctuality and low absenteeism
Able to work independently and as part of a team
Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
May need to lift up to twenty-five (25) pounds on occasion
Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.
Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Nice To Haves

Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred

Responsibilities

Develops and implements compliances programs centered around CGMP operations.
Conducts regular assessments and audits to evaluate compliance with applicable CGMP regulations for internal departments and 3rd Party Providers (i.e. Suppliers, Manufacturers, Contract Laboratories, etc.).
Identify areas for improvement and collaborate with internal stakeholders to support compliance during strategic planning and decision-making processes.
Provide companywide notifications when regulations and guidance, affecting 503B outsourcing facility operations, have been revised/updated.
Assist in responses and information transfers with regulatory agencies.
Analyzing regulatory developments and industry trends, providing insights and recommendations to enhance compliance strategy.
Responds to inquiries, assist in inspections, and ensures timely and appropriate reporting.
Champion the development and delivery of compliance training programs for employees, ensuring a thorough understanding of regulatory requirements.
Collaborating with various departments (e.g., Legal, Quality, R&D) to address compliance issues and ensure a holistic approach to risk management.
Perform internal audits of QMS ensuring adherence to applicable regulations and company policies.
Ensures proper documentation of manufacturing processes and maintains accurate records to demonstrate compliance.
Drives the implementation of corrective and preventive actions in response to compliance-related issues or identified areas for improvement.
Develops and maintains effective relationships with internal stakeholders, external partners, and regulatory bodies.
Collaborates with Quality Assurance and other departments to enhance the overall quality management system.
Fosters a creative and collaborative work environment, encouraging teamwork, professional growth, and knowledge sharing among team members.
Monitors and evaluates employee performance. Provides feedback as necessary.
Partners with department leadership to evaluate department headcount needs, conducts interviews and selects qualified candidates.
Performs other duties as assigned