Regulatory and Compliance Manager chez Swiss American CDMO

Description

Position Summary:  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.

Essential Duties and 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. 

Qualifications

Essential Skills and Qualifications:

• 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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This position is based in a professional office setting. The role primarily involves working at a desk using a computer for extended periods. TheReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment Is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position.  Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.