ESSENTIAL DUTIES AND RESPONSIBILITIES:
§ Interacts effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions. Ensuring that departmental timelines are met.
§ Reviews technical documents for accuracy and acceptability for use in new NDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high quality submissions and expeditious approvals from FDA.
§ Reviews and signs-off on change control documentation. Assess changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws.
§ Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.
§ Alongside Director, ensure regulatory program compliance for the company.
§ Monitor and assist Quality Control department in the maintenance the Quality Management System (QMS) to ensure compliance with FDA and other regulatory requirements.
§ Assist in the internal audit process, including the participation of GMP audits of the production facility on a regularly scheduled basis, and as necessary.
§ Secondary contact for all external audits.
§ Alongside the Director, assist in the external audit process, including preparation for ISO 9000 and customer audits.
§ Review customer and regulatory requirements to ensure company compliance and to stay abreast of new or updated regulations.
§ ISO 9000 and ISO 13485 management representative.
§ Secondary FDA contact, including assisting with the annual FDA registration updates and keeping Drug and Device listings current.
§ Ensure regulatory compliance on all materials and products.
§ Consult in reviews of NCMs to ensure trends or systemic issues are identified and addressed.
§ Assist in analyzing audit data and prepare reports for management review and continuous improvement initiatives.
§ Perform tests of controls to provide an evaluation of the company’s internal control system, and prepare audit reports for these tests, documenting exceptions to established policies and procedures.
§ Perform external quality audits on suppliers to ensure compliance with product specification.
§ Assist in overseeing the maintenance of Quality and Audit files for facility.
§ Assist in overseeing all Change Control activities to ensure compliance.
§ Review all release documents to ensure compliance with Standard Operating Procedures (SOPs).
§ Provide employee leadership through effective communications, coaching, training, and development. Provide leadership for problem resolution to facilitate fast improvements and improved working relationships.
§ Ensure compliance with GMP, QSR/ISO, FDA, NSF, NRC, ATF, OSHA, and all other regulatory requirements, in accordance with company policy.
§ Regular attendance required.
§ Adhere to company safety requirements.
§ Minimum of a Bachelor’s Degree in a life science or a related field, or a combination of equivalent education and experience.
§ Minimum 3 years’ experience providing GMP regulatory compliance in Manufacturing or Quality Assurance.
§ Minimum 2 years’ experience in an FDA manufacturing facility.
§ Detailed knowledge of GMP, ISO 9000, ISO 13485 and FDA requirements.
§ Proven experience implementing quality systems in a GMP environment.
§ Auditing certification preferred.
§ Excellent analytical and problem solving skills.
§ Demonstrated leadership skills and ability to get results through others.
§ Good communication and interpersonal skills.
§ Demonstrated project management experience.
§ Proficient with Microsoft Office (Word, Excel, Project).
§ Ability to manage multiple projects and prioritize to meet established timelines.
§ Frequently required to sit, talk, and hear.
§ Frequently required to stand and walk.
§ Occasionally required to lift up to 20 pounds.
§ Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
§ Ability to travel occasionally by air or car to attend business meetings and conduct audits.
Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.