Regulatory and Compliance Manager

Swiss American CDMO•Carrollton, TX

5d•$80,000 - $95,000•Onsite

About The Position

Responsible for providing oversight of internal/external and regulatory agency audits and working to ensure compliance with Swiss American CDMO, LLC procedures, ISO standards and FDA regulations. Main contact for clients regarding regulatory and compliance for Swiss American CDMO, LLC.

Requirements

Bachelor's degree in a relevant field (e.g., Law, Business, Science, Engineering) or equivalent.
Minimum 5 years in regulatory compliance, risk management, or related roles.
Proven track record of managing compliance programs and interacting with regulatory agencies
Industry-specific regulations (e.g., FDA, ISO).
Familiarity with compliance auditing and reporting processes.

Responsibilities

Has thorough knowledge of Quality Systems auditing principles and practices.
Participate in scheduling, and ensure completion of, ISO audits, Internal audits and customer audits.
Leads all ISO, FDA and customer audits.
Responsible for ensuring external (supplier/vendor) audits are conducted as appropriate.
Responsible for working with other employees to resolve compliance issues as appropriate.
Responsible for ensuring all CAPA found during audits are initiated.
Trains, supervises, motivates and develops a team of 4-6.
Manages schedules and workflow of a team of 4-6.
Liaise with R&D to ensure all new product development is done in accordance with applicable regulations and internal procedures.
Ensure follow up with personnel on audit CAPA.
Develop standard tools and procedures to improve audit efficiency.
Main contact for client requests regarding documentation for registration both domestically and internationally.
Assist In developing procedures to ensure regulatory compliance.
Create or maintain technical files as necessary to aid client in obtaining and sustaining product approval.
Assist in data analysis, preparation of and participation in Management Review.
Attends and participates in meetings as required.
Manages site post-market surveillance activities.
Manages pharmacovigilance activities.
Manages complaint handling process.
Responsible for Annual Review of Drug Products.
Responsible for Design File management/maintenance.
Responsible for regulatory input into change controls, nonconformances and CAPA.
Maintains professional growth and development through seminars, workshops and profession affiliations to keep abreast of latest trends In Industry.
Attention to detail is critical.
Other duties may be assigned.