Regulatory and Compliance Manager at Swiss American CDMO

Carrollton, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Mar, 26

Salary

95000.0

Posted On

18 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Quality Systems Auditing, ISO Standards, FDA Regulations, CAPA Management, Team Management, Client Liaison, Data Analysis, Pharmacovigilance, Complaint Handling, Post-Market Surveillance, Technical File Management, Risk Management, Auditing Processes, Documentation, Training and Development

Industry

Personal Care Product Manufacturing

Description

Job Details Job Location: Corporate - CARROLLTON, TX 75006 Salary Range: $80,000.00 - $95,000.00 Salary/year 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.

Responsibilities

The Regulatory and Compliance Manager is responsible for overseeing internal and external audits to ensure compliance with regulations and standards. They also manage a team and serve as the main contact for clients regarding regulatory matters.