What are the responsibilities and job description for the Quality Compliance Manager position at PCI Pharma Services?
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.
Manages strategies necessary to support customer's products as well as hosting and leading both regulatory inspections and customer audits. The Quality Compliance Manager is responsible for implementation of company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, and other ex-US regulatory agencies.
- Ensure compliance with domestic and international drug, device and biologic regulations with a strong focus on the FDA, DEA, and other ex-US regulatory agencies as required.
- Manage the Customer and Regulatory auditing program by completing required pre-audit documentation, hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation.
- Maintain a systematic approach to sharing audit (customer and regulators) observations and associated corrections with all facilities.
- Review and maintain appropriate Customer Quality Agreements.
- Review and maintain appropriate Site Master Files Implement programs that establish and maintain a culture that fosters compliance with company rules and all applicable federal, state, and local regulations. Utilize Continuous Improvement tools as required.
- Perform audits of suppliers determined to have potential cGMP impact per the corporate supplier management program.
- This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 thinking and creativity.
- Ability to adapt to changing work environments.
Join us and be part of building the bridge between life changing therapies and patients.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.