May 26, 2022
$90,000 - $120,000 yearly
Remote (Dallas, TX, USA)
The Manager of Operations/Quality Affairs, will be responsible for providing operational and quality leadership both strategically and in day-to-day activities. This individual will have sole responsibility for regulatory compliance related activities such as supplier management, change controls, deviations and general QMS maintenance. This individual will also ensure that the QMS and all business activities are in compliance with applicable US and international regulations and will be responsible for planning activities to ensure continued compliance. This role requires the ability to develop and maintain cooperative working relationships with team members to effectively ensure compliance and timeliness of both (vendor) manufacturing and regulatory activities.
- Manage the QMS to include CAPAs, Post-Market Surveillance, Training, Document and Change Control and Record Management.
- Manage audits (supplier audits as well as third-party, notified body or regulatory inspection)
- Manage risk control throughout the organization and its suppliers.
- Lead Quality assessment and oversight in all CMC submissions (including clinical trial, marketing and post-marketing applications, routine reports/renewals) and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures, to avoid undue delays or questions with product approvals.
- Maintain up-to-date knowledge of regional and global regulatory CMC and GMP requirements, analyze current trends and anticipate changes in the Regulatory requirements to adjust CMC strategic plans accordingly.
- Support and review dossiers and technical documents for submissions and recommend changes as appropriate to ensure approval and/or compliance with existing regulatory approvals.
- Provide quality assessments of manufacturing changes within the change control system and filing strategy guidance to, including supporting preparation for facility inspections of vendor sites by health authorities when necessary.
- Assist with managing regulatory agency interactions, document preparation, co-ordination of meeting rehearsals and minutes with a sense of urgency.
- Contribute to the development and implementation of short and long-term regulatory strategies for assigned projects and programs.
- Work effectively with all stakeholders in addressing GMP issues.
- Create and maintain Regulatory CMC development plans that are aligned with product development plans.
- Assist in due diligence and acquisition transfer activities.
- Initiate and manage process improvements.
- Lead and assist in compliance related activities originated by working with the Contract Manufacturing Organization (CMO). Initiate and manage Change Controls (CC).
- Work closely with various groups and sites/ warehouses to provide support in resolving any operational issues.
- Proactively identify operational risks and work with the team to develop contingency plans.
- The position is responsible for handling multiple projects with competing priorities.
- Solid understanding of US and International CMC and GMP requirements, regulations and best practices.
- Significant experience in supplier control and management
- Experience in regulatory assessments of post-marketing manufacturing changes and in preparing technical portion of INDs, NDAs, amendments, and supplements.
- Strong organizational and program management skills to maintain high level productivity, innovation and priority setting, completing assignments on time and on budget.
- Strong problem solving and diplomacy skills
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- M.S. degree in life/health/technical sciences
- Minimum of 5 years’ experience in a medical device, biotech and/or pharmaceutical environment
- Knowledge of global regulatory requirements
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Experience working in a start-up environment