Quality Assurance Associate Director
Resume:
I SABEL RESTIVO
QUALITY ASSURANCE, REGULATORY AFFAIRS AND COMPLIANCE
CONTACT PROFILE
************@*****.***
I am a professional with over 18 years of expertise in quality, regulatory, and compliance management. Drawing on a unique blend of biology, chemistry, regulatory and executive business administration, I had consistently optimized manufacturing processes and elevated quality standards. My efforts have ensured adherence to complex regulatory frameworks while driving process improvements that support operational excellence.
SKILLS EXPERIENCE
Lead Auditor
ISO 13485/EN ISO 13485
FDA 21 CFR
MDSAP
IVD/IDVR
MDD/MDR
CAPA, Complaint, PMS
Associate Director, Clinical Quality Assurance – CERUS, CA 2021- 2024
Responsible for overseeing compliance processes within the Clinical Quality Manufacturing (MFG) environment. Duties include performing and maintaining the Internal Audit Program for both the Quality Clinical and Quality
Commercial groups, as well as hosting and participating in Health Authority audits and inspections. Accountable for the on-time submission of all Health Authority requirements and ensuring conformance to specifications, GMP, and GLP regulations.
Associate Director Quality Operations – IMMUCOR, NJ 2018- 2021
Serves as a technical expert and Subject Matter Expert
(SME) in areas related to internal audits, compliance, and Health Authority inspections. Drives quality improvement initiatives in collaboration with key stakeholders. Coordinates with international Quality Contract Research Organizations (CROs) to support product release and regulatory filing or distribution requirements. Provides input for continuous monitoring of GMP compliance across the supply chain, including evaluating supplier quality incidents and escalating risks to Senior Management when
necessary.
EDUCATION
Fairleigh Dickinson University
Certificate in Administrative
Science
New Jersey Institute of
Technology
MBA
Fairleigh Dickinson University
MS, Masters Biology
Fairleigh Dickinson University
BS, Bachelor of Science,
Biology
Sr. Global Manager Quality Assurance- SIVANTOS, NJ 2017- 2018
Ensured timely preparation and submission of all required reports, trending analyses, and metrics. Maintained strict adherence to FDA rules and regulations, while staying up to date on evolving regulatory requirements. Established a monitoring program designed to respond constructively to audit activity. Verified that all processing records complied with processing specifications and Quality
System/Regulatory Compliance standards prior to product release.
QS/RC Manager – STERIS, NJ
2015- 2017
Served as the facility’s Corporate Quality Representative, ISO Management Representative, and Regulatory
Representative. Planned and conducted document
reviews, as well as internal and external (customer-driven) audits, to assess compliance with FDA regulations, regulatory commitments, company procedures, and
contractual obligations. Led quality system initiatives aligned with the STERIS AST quality system and played a key role in implementing and communicating new or revised Quality System and Regulatory Compliance policies and procedures.
Manufacturing Supervisor/Quality Specialist – SANOFI, NJ 2010- 2015
Supervised the aseptic production of both syringe and intravenous injectable products, overseeing day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities for the Vial/Syringe Manufacturing Department. Proficient in SMART SOP/BPR creation and conversion, and developed and reviewed documents such as Batch Records, Standard Operating Procedures, Engineering Reports, Risk
Assessments, and technical reports to ensure alignment with FDA regulations.
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