Careers – Regulatory Compliance Manager – Albuquerque, NM USA
The Regulatory Compliance Manager provides leadership and is responsible for establishing and maintaining management systems and processes that meet the quality requirements of the company; establish and maintain compliance systems in support of medical device software which meet applicable regulatory, compendia, and statutory requirements and guidelines; ensure that all QA systems and practices are implemented and followed for internal operations and outsourced work with contractors and third party vendors; manages activities related to product release, stability, validation, adherence to ISO/FDA/GXP/CE standards, vendor audits, change control, document management, and QA training; collaborates with key stakeholders to ensure compliance of development activities with appropriate regulatory requirements, including support for inspections, audits, and FDA submissions. The position involves the following essential functions:
Duties and Responsibilities
- Lead development of the company’s QMS in keeping with evolving needs, for compliance to GXP/CLIA/FDA/ISO/CE requirements and for continued improvement in compliance and operational efficiency.
- Chair management review process, documentation and follow-up
- Internal audit function
- QMS training for staff
- Review, investigate and respond to all complaints
- Promote quality achievement and performance improvement throughout the organization and with key vendors.
- Sets compliance objectives in alignment with business objectives and ensure that targets are achieved.
- Provide oversight of compliance of third parties to QMS agreements.
- Manage QMS document access, new document creation, revisions and necessary training. Ensure documentation is in compliance with global regulatory filings and applicable global regulatory requirements.
- Establish and manage budgets for the unit.
- Define and implement quality system procedures and policies.
- Develop proposals for system and process development or modification to support the company’s mission of continuous improvement.
- Develop/review SOPs/documents to fulfill global development requirements.
- Assist in the establishment of product and material specifications and ensure that product complies with specifications and meets all necessary standards for safety, purity, identity and efficacy.
- Review or oversees the review and approval of deviations and change control to all documents and investigates the results of product and/or process non-conformance.
- Establish a vendor audit plan and ensure timely audits and effective closure of quality issues of supplier and contract organizations providing critical raw materials or performing GXP services.
- Maintenance of CAPA system. Lead or oversee any investigations and ensure the execution and closure of CAPA plans.
- Participate in the review of quality sections of contractor agreements and leads the preparation and approval of QA Agreements and ensure operations and activities are in compliance with such approved agreements and QMS.
- Provide detailed project timeline and budget projections related to QA operations in support of the company’s development programs.
- Maintain document control system
- Support the internal transition of paper to electronic files and transfer of legacy documents associated with product license/acquisitions.
- Effectively manage the company’s document and material management system including oversight of off-site storage of active and archived materials.
- Regularly meets with Product Development, Quality & Regulatory affairs to report quality issues and resolutions, review recent results, set next plans, and assure appropriate progress is being made on assigned programs.
- Maintains a clean and safe work environment and follows all safety policies and procedures.
- Provide leadership, establishing, and maintaining quality management systems and processes that meet the quality requirements of the company.
- Bachelor’s Degree
- Four (4) years of related experience in pharmaceutical or medical device compliance/regulation industry
- Equivalent combination of education or experience may be substituted on a year for year basis.
This position is based at our headquarters in Albuquerque, NM.
Working Conditions and Physical Effort
- Some travel may be required (<10%)
- No, or limited physical effort required
- No, or limited exposure to physical risk
- Work is normally performed in a typical interior/office work environment
Special Instructions to Applicants
For best consideration, candidates are required to submit their Resume/CV and Cover Letter to firstname.lastname@example.org