Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
1. Ensure compliance with applicable domestic and international drug, device, and biologic regulations, with a strong focus on FDA, DEA, and other international regulatory agency requirements, as applicable.
2. Coordinate and oversee the customer and regulatory audit program, including completion of required pre-audit documentation, hosting audits, coordinating audit responses, documenting corrective actions, and ensuring timely implementation and closure of identified actions.
3. Maintain a systematic approach to communicating customer and regulatory audit observations, corrective actions, and lessons learned to applicable departments and facilities.
4. Review and maintain Customer Quality Agreements to ensure alignment with applicable regulatory requirements and site operations.
5. Review and maintain Site Master Files and associated compliance documentation, as applicable.
6. Support the implementation and maintenance of programs that promote a culture of quality and compliance with company policies, procedures, and applicable federal, state, and local regulations.
7. Utilize continuous improvement tools to identify opportunities for process improvements and strengthen compliance activities.
8. Perform or coordinate audits of suppliers identified as having potential cGMP impact in accordance with the corporate supplier management program.
9. Support ongoing inspection readiness activities to ensure the site maintains compliance with applicable regulatory requirements and internal procedures.
10. Monitor and follow up on audit observations and associated corrective and preventive actions (CAPAs) to ensure timely completion and effectiveness, as applicable.
11. Provide day-to-day supervision, guidance, and oversight of assigned Quality Compliance personnel, including workload prioritization, training, performance management, and ensuring activities are completed accurately, efficiently, and in accordance with established procedures.
12. Maintain knowledge of and adherence to all applicable PCI policies, procedures, cGMP, and GCP requirements, as applicable.
13. This position may require overtime and/or weekend work based on business needs.
14. Regular and reliable attendance is an essential function of this position.
15. Perform other duties as assigned by Quality Management.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
Required:
- Bachelor's Degree in a related field and/or 3-5 years related experience and/or training.
- College Level Mathematical Skills
- Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
- High Standard of Report Writing
Preferred:
- Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
- Ability to display original…