Regulatory Affairs Supervisor

Regulatory Affairs Supervisor

Reports To

Director of Quality Assurance

Scope of Supervision

Quality Assurance personnel

GENERAL PURPOSE

The Regulatory Affairs Supervisor is responsible for oversight of all Regulatory Affairs activities and supports core Quality Assurance functions.

POSITION RESPONSIBILITIES

· Supports and serves as the primary backup to the Director of Quality Assurance.

· Professionally develops direct reports to maximize individual and overall performance.

· Oversee, manage and facilitate the workloads of personnel to meet company expectations.

· Ensure quality system /regulatory requirements are met (e.g. cGMP, CFR’s, Food Safety, FSMA, FSVP, etc.).

· Assist in identifying and implementing quality system enhancements to achieve/maintain third party quality system certification.

· Oversee the management and compliance of the supplier/vendor management program (FDA FSVP); ensuring suppliers and outsourced labs are qualified/re-qualified, as dictated by FDA/FSMA.

· Oversee and improve the Internal Audit program (which may include Mock Recall, Food Defense, Food Safety, Disaster Recovery, Business Continuity, Certifying Body Audits), including scheduling, planning, conducting and reporting, close-out and follow-up corrective actions. This includes focus on GMP compliance, and regulatory.

· Ensure facility is properly permitted / licensed / certified regarding regulatory/3rd party agencies (e.g. US/FL Dept. of Ag., State, Federal, DEA, NSF, etc.).

· Interface with supplier, customer quality representatives, and regulatory agencies -as required. Prepare and ensure customer readiness / inspections.

· Oversee the review of product labels for applicable regulatory / certification claims compliance.

· Oversee the Food Safety/Defense Program ensuring the plan is adequate and meets regulatory requirements.

· Oversee the management of HACCP/HARPC Programs ensuring regulatory compliance.

· Prepare, revise, review and approve, as required, SOPs and related documentation per company change control policies.

· Maintain an active role on continuous improvement teams.

· All other duties as assigned.

· Willing to work holidays and weekends as requested.

MINIMUM QUALIFICATIONS

Education:

• Bachelor’s Degree, preferably in Engineering or Life Sciences or related field, or equivalent experience.

Experience:

• Minimum 10 years of experience in cGMP environment, such as Drugs, Cosmetics, Dietary Supplements, or Medical Devices.


• Minimum 5 years of management or supervisory experience.


• Experience in supervising / managing at a cGMP facility.

Knowledge, Skills and Abilities:

• Knowledge of cGMPs, 21 CFR 110, 111, 701 and Standard Operating Procedures


• Strong computer skills to include full competence with MS Word, PowerPoint, Outlook, Excel, and Visio


• Proven Knowledge of Quality Assurance/Control systems, HACCP/HARPC, GMP and Sanitation principles


• Team development and leadership skills


• Strong proofreading and writing skills (reports, SOPs, protocols, etc.)


• Must have a good interpersonal and communication skill in English, understand both oral and written instructions and be detail oriented.


• Food Safety/HACCP Certification, Quality Auditor Certification desirable


• Ability to lift up to 30 lbs.

Job Type: Full-time

Pay: $50,000.00 - $70,000.00 per year

Benefits:

• 401(k)


• 401(k) matching


• Dental insurance


• Employee assistance program


• Flexible spending account


• Health insurance


• Health savings account


• Life insurance


• Paid time off


• Referral program


• Retirement plan


• Vision insurance

Schedule:

• Day shift


• Monday to Friday


• Weekends as needed

Supplemental pay types:

• Bonus opportunities

Ability to Relocate:

• Largo, FL 33773: Relocate before starting work (Required)

Work Location: In person