PONYA LABORATORY SERVICES
Director of Quality Assurance – Therapeutics Division
PONYA LABORATORY SERVICES, Atlanta, Georgia, United States, 30383
Overview
Ponya Lab Services is seeking a seasoned Quality Assurance professional for our Therapeutics Division to lead Quality Assurance and compliance across our biologics, regenerative medicine, device, and wound care product line and pipeline. The successful candidate will complete the implementation of a 21 CFR 1271, 21 CFR 820, and ISO 13487 compliant Quality Management System and ensure inspection readiness. Proven expertise in all aspects of Quality including Change Management, Risk Management, Deviations and CAPA, Supplier Qualification and Management, Equipment Qualification, Materials Management, and Process Validation is required. Experience in Design Controls and the pre-commercial phases of medical device development is desirable but not required. Candidates with experience in providing Quality support to an ISO 14644-compliant cleanroom facility will be given preference. The successful candidate will have a B.S. degree or higher in a scientific discipline or biomedical engineering to bridge Quality Assurance and a technical understanding of our tissue-based products and our patient populations. If you have 10+ years of Quality leadership experience in biotech, pharma, or medical devices, a deep understanding of regulatory frameworks, and a passion for patient-centered innovation, this is your opportunity to shape the future of Therapeutics. Responsibilities
Lead Quality Assurance and compliance across biologics, regenerative medicine, device, and wound care product lines and pipelines. Implement and maintain a 21 CFR 1271, 21 CFR 820, and ISO 13487 compliant Quality Management System and ensure inspection readiness. Manage Change Management, Risk Management, Deviations and CAPA, Supplier Qualification and Management, Equipment Qualification, Materials Management, and Process Validation activities. Provide Quality support in Design Controls and, when applicable, contribute to pre-commercial medical device development efforts. Support ISO 14644-compliant cleanroom operations where applicable. Collaborate with cross-functional teams to bridge Quality Assurance with technical understanding of tissue-based products and patient populations. Qualifications
B.S. degree or higher in a scientific discipline or biomedical engineering. 10+ years of Quality leadership experience in biotech, pharma, or medical devices. Deep understanding of regulatory frameworks applicable to the role. Strong communication and collaboration skills with a patient-centered focus on innovation. Employment details
Seniority level: Director Employment type: Full-time Job function: Quality Assurance Industries: Medical and Diagnostic Laboratories We are an equal opportunity employer. Referrals increase your chances of interviewing at PONYA LABORATORY SERVICES. This posting does not include any other job postings or external notices.
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Ponya Lab Services is seeking a seasoned Quality Assurance professional for our Therapeutics Division to lead Quality Assurance and compliance across our biologics, regenerative medicine, device, and wound care product line and pipeline. The successful candidate will complete the implementation of a 21 CFR 1271, 21 CFR 820, and ISO 13487 compliant Quality Management System and ensure inspection readiness. Proven expertise in all aspects of Quality including Change Management, Risk Management, Deviations and CAPA, Supplier Qualification and Management, Equipment Qualification, Materials Management, and Process Validation is required. Experience in Design Controls and the pre-commercial phases of medical device development is desirable but not required. Candidates with experience in providing Quality support to an ISO 14644-compliant cleanroom facility will be given preference. The successful candidate will have a B.S. degree or higher in a scientific discipline or biomedical engineering to bridge Quality Assurance and a technical understanding of our tissue-based products and our patient populations. If you have 10+ years of Quality leadership experience in biotech, pharma, or medical devices, a deep understanding of regulatory frameworks, and a passion for patient-centered innovation, this is your opportunity to shape the future of Therapeutics. Responsibilities
Lead Quality Assurance and compliance across biologics, regenerative medicine, device, and wound care product lines and pipelines. Implement and maintain a 21 CFR 1271, 21 CFR 820, and ISO 13487 compliant Quality Management System and ensure inspection readiness. Manage Change Management, Risk Management, Deviations and CAPA, Supplier Qualification and Management, Equipment Qualification, Materials Management, and Process Validation activities. Provide Quality support in Design Controls and, when applicable, contribute to pre-commercial medical device development efforts. Support ISO 14644-compliant cleanroom operations where applicable. Collaborate with cross-functional teams to bridge Quality Assurance with technical understanding of tissue-based products and patient populations. Qualifications
B.S. degree or higher in a scientific discipline or biomedical engineering. 10+ years of Quality leadership experience in biotech, pharma, or medical devices. Deep understanding of regulatory frameworks applicable to the role. Strong communication and collaboration skills with a patient-centered focus on innovation. Employment details
Seniority level: Director Employment type: Full-time Job function: Quality Assurance Industries: Medical and Diagnostic Laboratories We are an equal opportunity employer. Referrals increase your chances of interviewing at PONYA LABORATORY SERVICES. This posting does not include any other job postings or external notices.
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