|Specific Duties and Responsibilities:|
We are currently seeking several experienced Regulatory Affairs professional at various levels (Director/Manager/ Regulatory Associate) for our RA team based in a Chicago Suburb. The Director/Manager will lead a group QA Associate in support of our specialty pharmaceutical drug product development in support of ANDA submissions and commercial manufacturing activities. This person will also oversee various external product development collaborations with various CRO laboratories and be responsible for the audit of the external facilities.
- Develop, implement, audit, manage and maintain cGMPs and cGLPs, quality management systems (SOPs) to support commercial and development activities of the pharmaceutical drug products in different configurations.
- Oversight to all the QA systems.
- Develop, implement review and approve all SOP's, Protocols and specifications.
- Develop, review and approve all training programs and records,
- Ensure that cGMP requirements and quality standards are well understood and maintained across the company.
- Ensures that all the departments (development, manufacturing, Regulatory) are in compliance and are ready for inspection by Regulatory agencies.
- Keep the company management and employees abreast of all the new FDA regulations and changes along with their business implications.
- Develop systems and implement vendor compliance audits.
- Ensure that appropriate in-process and manufacturing controls are developed and implemented.
- Manage and resolve all out of trend results and investigations (NOE, Deviations, OOS, NCR,
- CAPA).Ensure investigations are conducted and root causes are identified and eliminated for production control errors and discrepancies in quality attributes.
- Present periodically all the unresolved data issues, customer complaints, deviations and change controls to the managements.
- Report outcome of any kind of Regulatory inspections/audits and ensure that responses are completed in timely manner and manage the closure of the citations.
- Provide quality guidance to product development projects and programs.
- Provide oversight and QA guidance for all the facility design, expansion and construction.
- Provide support to all Engineering and Manufacturing projects and investigations.
- Represent QA at all senior management meeting.
- Develop QA department and carrier path for QA personnel.
- Oversight to all ongoing training and orientation programs.
- Prepare Job Descriptions for the QA staff.
- Perform staff performance reviews.
- Provide quality guidance from the inception of the project to the launch of the product.
- Provide guidance for responding to all the QA issues came up during FDA Audits
- Represent QA at the FDA and other regulatory agencies
Education Minimum / Recommended:
- BS/MS degree in chemistry or pharmaceutical or Analytical or Engineering.
Work Experience Required:
- 5 to 10 years’ experience in generic injectable setting with increasing responsibility.
- Experience working with oncology products is a strong plus.
- Demonstrated experience of responding to the FDA compliance issues and communication
- Demonstrated remediation experience for any
- In depth working knowledge of cGMPs, cGLPs, QSR, ISO 13485, ISO 9001.
- Developing and implementing quality systems within pharmaceutical / medical device industry.
- Ability to understand scientific, quality and regulatory information.
- Experience in releasing new approved product for commercialization.
- Excellent Skills in Reading, Writing, Verbal Communication, Mathematics, Computer, etc.
- Excellent organizational, communication, teamwork, and interpersonal skills
- Must be able to work independently and have good time management skills
- Excellent Microsoft knowledge and experience
- Proficient in writing.
- Excellent attention to details for reporting and FDA submissions.
- Strong management and leadership qualities.