Stan Reid Email & Phone Number

Tarrytown, New York, Us

Assures Product conformance to established requirements and standards through appropriate inspection and test activities. Management Representative for all external audits (FDA, CDMR, BSI, TUV). Provide Quality guidance and support for Change Controls, CAPAs and Investigations • Review and approval of manufacturing batch records, analytical testing records, and technical documents, as well as Quality release of batch documentation for disposition.• Authored, reviewed, and approved quality policies, SOPs, and work instructions for areas of responsibility.• Develop, maintain, and execute an Audit schedule of current CMO partners; audit potential new CMO sites.• Established, maintained, and executed an approved supplier qualification and change notification process as well as oversite of Quality Agreements• Monitored performance metrics and drive continuous improvement (external supplier partners and internal processes). • Quality oversite on Technology Transfer teams for process and analytical method transfers.• Reviewed and approved of manufacturing batch records, analytical records, and technical documents, as well as preparation of batch documentation for disposition. • Conducted complaint investigations. • Established, maintained, and executed an approved supplier qualification and change notification process including (SCAR’S).• Provided Quality guidance for Deviations, Process Exceptions, Change Controls, CAPAs and Investigations.

This position is responsible for managing the Quality Laboratories, Quality Assurance, Quality Systems, Regulatory Affairs, Validation and Technical Services departments of the company. • Direct, coordinate and assure compliance in activities related to the interaction, inspections, and required submission data (DMF’s, LOA’s, etc.) to the regulatory agencies such as the Food and Drug Administration (FDA) and Canadian Health Authorities (HPB). • Ensure that the Microbiology, Chemistry and Color Laboratories function according to approved procedures and regulations.• Manage and coordinate the quality activities of: incoming/in-process inspections, laboratory operations, stability, compliance, documentation, product release, validations, qualifications, process improvements, product developmental activities and customer inquiries relative to the business.• Ensure Product Complaint and Incident Program functions in a timely manner relative to the coordination with the Technical Services Support Personnel, external and internal investigation process, on-site visits, follow-up for customer resolution and product disposition.• Oversee Customer Audit Program.• Assist in the development of strategies, tactics, training, programs and activities related to assuring compliance with regulations, investigations of product complaints/incidents, certification of vendors, and transfer of products and technology.• Develop, administer and monitor the department’s budget.• Participant in the long-range corporate planning initiatives to ensure that future Quality System objectives will be met, i.e., working with established KPI’s for the facility and other departments to ensure corporate objective goals are met.• Oversee, participate and approve the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units.

Cambridge, Ma, Us

Cambridge, Ma, Us

, The Sr. QA Manager, Supply Chain Quality is responsible for quality operations of clinical and commercial product. The responsibilities include product disposition and quality oversight of partners with respect to quality issues, deviations, investigations, CAPAs and validation. Specific Responsibilities: • Manage the QA interface with manufacturing and testing partners for clinical and commercial product ensure quality issues are tracked and resolved in a timely fashion. • Prepare/manage Quality Agreements with manufacturing and testing partners for commercial product. • Ensure deviations are fully investigated, corrective actions identified and implemented and CAPAs completed as planned.. • Review and approval of validation protocols and reports. • Review manufacturing and testing documentation and perform batch disposition. • Ensure timely investigation of product complaints. • Revise/develop SOPs to document the work processes for Supply Chain Quality responsibilities and activities. • Prepare status reports. • Update logs, databases as appropriate. • Other duties as assigned. Qualifications: • BA/BS in Life Sciences and 10 years experience in biotechnology or pharmaceutical industry. • Oversite of pharmaceutical drug manufacturing, testing and disposition. • Strong understanding of cGMPs, GLPs, GCPs, ICH and FDA guidelines and regulations. • Demonstrated ability to work effectively with various groups to assure conformance to regulatory requirements, internal processes, and policies.

New York, New York, Us

Thousand Oaks, Ca, Us

Leverkusen, North Rhine-Westphalia, De

Leverkusen, North Rhine-Westphalia, De

Bs, Biology, Management

B.S., Science

As, Business