Robert Jerez Email & Phone Number

Pennsburg, PA, US

New York, New York, US

New York, New York, US

New York, New York, US

• Head of Quality for a virtual pharmaceutical company.
• Create and maintain Quality and Compliance systems for the new company, including the onboarding of Contract Manufacturer and Packager, Third Party Logistics (3PL’s), Call Centers and Serialization vendors.
• Facilitate the creation of processes and procedures for Medical Affairs, Marketing, Legal and other critical departments in support of a new product launch.
• Lead commercial site transfer activities at Contract Manufacturing facilities.
• Lead and review Contract Manufacturer and Packager batch record and investigations and develop a partnership with relevant site personnel to ensure compliance.
• Host and respond to FDA audits at the company site in support of Contract Manufactured product, including Pre-Approval and Pharmacovigilance Audits.

Hayward, CA, US

• Ensure compliance to all GMP regulations for the Company’s Third Party products. Responsible to implement, monitor and audit quality programs for the Company’s 40+ Contract Manufacturers, Packagers and Testing Sites.
• Lead a team of six professionals and department budget.
• Complete knowledge transfer of new products, either through acquisition or development, to ensure quality and integrity.
• Lead the review and disposition of Quality Records, including Batch records and Testing Records and disposition as appropriate.
• Communicate and monitor company Quality Initiatives and Standards to be followed at the Contract Organizations, including drafting and enforcing Quality Agreements.
• Lead and review Contract Manufacturer and Packager investigations and develop a partnership with relevant site personnel to ensure compliance.

• Continuation of Associate Director Responsibilities.
• Lead a team of two professionals.
• Lead the integration of the Amedra holdings and systems into Impax Laboratories.
• Implement the transfer of all company products to a new Third Party Logistics site.

• Continuation of QA Account Manager Responsibilities.
• Research, procure and implement an electronic Quality Management system to support a virtual Contract Manufacturing Organization.

• Responsible for communication, oversight, and monitoring of the Contract Manufacturing Organizations quality programs along with the administration, management, and execution of internal Quality Systems.
• Create and maintain Quality and Compliance systems for the new company.
• Communicate and monitor company Quality initiatives and standards to be followed at all contract manufacturing, warehousing and distribution sites.
• Perform the review of all Batch Record Documentation including laboratory test results, investigations, and deviations.
• Support and review CMO investigations (manufacturing, packaging, laboratory, supplier) and develop a partnership with the site quality personnel to ensure conformance with cGMP’s.
• Investigate health care professional, and consumer complaints stemming from products manufactured on behalf of the company. Work cross functionally with Regulatory Affairs to coordinate and manage all complaint and.

Raritan, New Jersey, US

• Provide oversight for projects teams and application changes to assess impacts to data quality, architecture and standards.
• Provide guidance and direction on data management policies, by creating enterprise wide standards and processes.
• Assess impacts of changes within and across functional areas that impact SAP & master data, as well as quality systems supporting CAPA, event/deviation management, change control and others.
• Establish data relationships, and generate accurate source-to-target mapping between different data structures and define the necessary transformation specifications.
• Creation and continuous improvement on data standards, processes and applications.

US

• Manages and executes the site Quality Systems such as CAPA, Metrics, and Management Review for all Operations areas such for compliance to Local, Federal and International regulations and company and corporate.
• Manages the Quality Assurance activities of the Sampling & Inspection and Record Review and Control groups to assure that components and product meet established quality standards and are released on time.
• Conduct and approve Quality Investigations and Deviations.
• Represents the Company in all contact with the FDA, DEA, and other government regulatory agencies where appropriate.
• Act as Calibration Officer, ensuring accurate records are kept, as well as assist with organizing inspection scheduling and reporting.
• Manage Logistics/Operations/Engineering/Compliance Department projects from internal and external departments, suppliers and subcontractors. Develops and implements systems and training to ensure successful completion.

US

• Provide principle compliance management support to New Product Development of Global McNeil and J&J/Merck NDA, OTC and Medical Device products.
• Approve the compliance integrity of R&D development data including Development Reports and CMC Submissions.
• Responsible for the generation of Quality Systems to support Medical Device initiatives in US and Asia.
• Perform Due Diligence Audits in collaboration with the New Business Development teams.
• Execute Contractor and Supplier audits with follow-up on responses and corrective actions.
• Apply Lean and Process Excellence methodology to various Quality Assurance projects.

US

• Conduct Pre-Approval Inspections of domestic and international sites prior to regulatory submissions. Coordination of corrective action plans to assure sustainable compliance.
• Perform QSIT audits of the global manufacturing facilities.
• Lead Cross Functional teams across several different sites to support compliance initiatives.
• Completion of Key Quarterly Reports for upper management.

New Brunswick, NJ, US

• Direct quality management for contract locations in Wound Care and Kids Franchises, producing OTC, Cosmetic and Medical Device products in US, Europe, Mexico and Japan.
• Completion of Wound Care, Oral Health and Women’s Health Annual Drug Product Reviews.
• Responsible for the maintenance of the Marketed Product Stability Program of Contract Products across all Franchises for OTC, NDA, Cosmetic and formulated Medical Devices.
• Audit External Manufacturers, Packagers and Contract Laboratories against GMP, GLP, QSR, and ICH guidelines.
• Apply 6- Sigma Process Excellence methodology to various Quality Assurance projects.

SBS International - Quality Assurance SpecialistStryker Medical - Quality ManagerRCM Technologies - Project ManagerGanes Chemicals - Senior Quality Assurance Auditor

Mba, Business Administration

Bs, Biology