Senior Manager, Regulatory & Compliance
- Job Title
- Senior Manager, Regulatory & Compliance
- Job ID
- CARROLLTON, TX 75006-6623
- Other Location
Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skin care technologies to selected markets. Our business strategy consists of development, manufacturing and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity and commitment.” Are you passionate about Service Excellence, Results, Integrity and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.
Senior Manager, Regulatory & Compliance
The Senior Manager, Regulatory & Compliance is responsible for providing oversight of internal/external and regulatory agency audits and working to ensure compliance with Swiss American procedures, ISO standards, applicable global laws and regulations (i.e. Korea, Canada, Japan, etc.) and FDA laws and regulations. This professional is also responsible for managing regulatory and compliance intelligence, policies and programs of diverse scope across the business. Responsible for site post-market surveillance activities. Frequently interacts with business and cross-functional colleagues and departments to develop correction action plans and effectively manage changes to ensure compliance with regulatory requirements. This function and related data feeds into risk assessment activities across the site/business Quality Management System and provides executive management visibility into the health of activities across Swiss American. Time is split between moderate to high risk regulatory projects and management of a small team of regulatory and compliance specialists and associates.
Essential Duties and Responsibilities include the following. Other duties may be assigned:
- Review and assess changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised Quality systems processes.
- Responsible for ensuring the scheduling and preparing for regulatory body audits (including but not limited to ISO, State, and FDA) audits, internal audits and external audits (including but not limited to customer and other regulatory agencies).
- Responsible for preparing for and being in attendance for internal and external audits/inspections.
- Responsible for ensuring that external audits are conducted as appropriate.
- Responsible for working with other employees to resolve compliance issues as appropriate.
- Responsible for ensuring that all CAPAs are initiated for observations found during audits.
- Train, supervise, motivate and develop team.
- Manage schedules and workflow of a team of 2-4.
- Responsible for new ingredient approval, secondary ingredient source approval, and reviewing product charter.
- Responsible for global ingredient/formula compliance review, Prop 65 and California labeling requirements.
- Responsible for review of in-house created and customer created labeling for appropriate claims.
- Responsible for site pharmacovigilance.
- Follow-up with personnel on CAPA reports that were opened due to internal/external audits.
- Develop standard tools and procedures to improve audit efficiency.
- Responsible for coordinating regulation compliance for multiple countries.
- Will participate in reviewing key FDA and other countries submission reports.
- Assist in developing procedures to ensure regulatory compliance.
- Oversee the creation and/or maintenance of technical files [a file demonstrating compliance with the essential requirements (Annex I of the 93/42/EEC)] as necessary to obtain and sustain product approval.
- Support clients with required documents for CMC (or similar) sections of regulatory submissions.
- Serve as internal resource for assembly and authoring of 510k files.
- Determine and communicate submission and approval requirements early in the product lifecycle to assure that project plans are aligned with submission strategies and regulatory guidelines.
- Write regulatory documents for suitability for submission to FDA and any other regulatory agencies, as needed.
- Under the direction of the Director of Quality & Regulatory Affairs, handle the preparation of submission packages for regulatory agencies in compliance with applicable requirements and best practices.
- Identify issues early in the submission preparation process that could impact timelines/risks.
- Participate in multidisciplinary project teams with the Client.
- Assist the Director of Quality & Regulatory Affairs with the company's progress into commercial readiness efforts.
- Maintain knowledge base of existing and emerging regulations, standards, or guidance documents that could impact Swiss American's contract manufacturing strategies.
- Assist with training staff on regulatory requirements for submission across regulatory paths and agency interactions.
- Maintain Regulatory Intelligence tracker and supporting documentation repository.
- Partner with the Quality Systems and Operations groups to establish and confirm compliance metrics and trends for CAPA and commitments for Quality Management Reviews.
- Partner with the Quality Systems and Operations groups to identify compliance trends that will feed governance reports.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Attention to detail is critical. Thorough knowledge of Quality Systems and auditing principles and practices is essential.
- Education: Bachelor’s Degree in Business or Life sciences is required; Advance degree is preferred.
- Experience: Minimum 6 years pharmaceutical or biotechnology industry experience in a quality/regulatory function.
- Experience managing and supporting GxP inspections is required.
- GxP expertise is required.
- Disciplined, detail orientated and excels in project management.
- Proficient knowledge of the pharmaceuticals R&D, product development, regulatory and quality environments.
- Deep knowledge of applicable global regulatory requirements.
- Experience with process management and continuous improvement.
- Computer Skills: Knowledge of Microsoft Office Business Suite and Internet software.
- Certificates and Licenses: RAC preferred.
- Supervisory Responsibilities: Ability to be responsible for supervising a team of 2-4 personnel.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.