Executive Director Quality& Regulatory Resume
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Rochester, NY
SUMMARY:
- Highly skilled and motivated Quality Professional wif >20 years’ experience in Quality Assurance and Compliance Management looking for a Senior Management/Executive position in Pharmaceutical, Biotech, Medical Device industry.
- Proficiently spearheaded teh development and execution of Quality Systems for three new Pharmaceutical Manufacturing facilities startup and successfully, laid out Quality Systems and Quality Organization, built a team, Lead teh team to get Regulatory approval, managed product development, Tech Transfer, commercial manufacturing and TEMPeffectively accomplished cGMP compliance as per US and international standards and per international Quality standards.
- Expertly executed quality plans for over 30 Prescription Drug Products, efficiently drove teh GXP compliance during Pre - Clinical and Clinical development for NDA/BLA submissions, Designed Quality Systems and managed teh GMP compliance throughout teh commercial manufacturing, for Aseptic & Non-Aseptic Pharmaceuticals, as well as multiple Nutritional, Consumer Health, Cosmetics and OTC Products.
- Successfully Hosted and closed more than 20 FDA and other regulatory Inspections and numerous customer Quality Audits in last 5 years wif no-critical observation, drafted responses, designed & Executed teh CAPA plans, addressed teh gaps and Communicated wif Agencies.
- Skillfully Designed Site Quality Systems, Procedure, Processes and QA tools and successfully implemented on multiple drug manufacturing sites, wif an improvement in overall site compliance performance against KPIs, for key Quality Systems such as, Materials Control, Supplier Management, External Manufacturing, Complaint Management, GMP Deviations, Change control Management, CAPA management, Production process control, & Product Release, Quality Risk Management,, and Audit Program Management.
- Performed as subject matter expert and proficiently advised and coached Manufacturing sites on aseptic manufacturing Processes, Environmental control and Monitoring program, Aseptic Process Qualification, Validation, Risk Management, Product Sterilization, Sterility Assurance, technology transfer and Microbiological Aspects of product development.
- As a Corporate Quality Leader, streamlined quality system & processes and designed Lean procedures, TEMPeffecting continuous improvement and consistent compliance performance, changed Quality mindset and established a quality culture resulting in Improved business performance at a reduced cost and expense on human resources wif improved Compliance Performance at multiple Manufacturing sites
- Instrumental in designing and executing Customer focused product development management process for NDA, ANDA & BLA products & Design Control management strategy for medical device products in Global R&D center, resulting in timely Approval and delivery of TEMPEffective and safe products.
PROFESSIONAL EXPERIENCE:
Confidential, Rochester, NY
Executive Director Quality& Regulatory
Responsibilities:
- Executive leader & change agent provided vision & direction to teh Quality Assurance, Regulatory Affairs, and DEA organizations, wif excellent GMP Compliance performance in delivering Quality products wif customer satisfaction and target financial performance.
- Managed human, financial, and technical resources wifin Quality organization and met teh goal of site FDA approval for Sterile Manufacturing start up and fulfilled performance goals and objectives in nonsterile operation.
- Realigned teh structure of Quality Organization and built a strong team through culture change, team building and Job based for excellence in maintaining Sterile manufacturing facility and BFS operation.
- Revamped Quality systems Design elements and Documentation to implement lean, efficient and simplified processes as per current regulatory standards to ensure full GMP compliance in manufacturing and speed to market.
- Implemented process of QA oversight on day-to-day operations, identified opportunities for process improvements and rolled out Greenbelt projects & CAPA plan, that resulted improved finished product Yield, minimized product failure rate, reduced # of deviations and non-conformance, reduced documentation errors, improved data integrity, and improved communication wif customers and suppliers.
- Streamlined Quality & Regulatory processes for managing, customer audits, GMP compliance during Product Development, and Supplier management.
Confidential, Abbott Park, IL 60064
Global Program Manager
Responsibilities:
- Managed Quality performance of Abbott Manufacturing Sites World over in teh key Global Quality Systems such as, Building, Facilities & Utilities, Laboratory operations, and Materials Management.
- Performed Regulatory Intelligence for Impact assessment on Abbott Quality Systems due to changes in Global Regulatory requirements and Standards and performed Regulatory mapping of Policies & Standards, & updated teh Quality Systems accordingly.
- Performed Predictive Data Analysis by Quality Trending of Compliance gaps identified during internal and external audits and worked wif site Quality leadership to develop & Implement Corrective Action Plan.
- Performed site Audits and Regulatory Compliance Assessment for inspection readiness.
- Provided Quality and Regulatory Technical support as a Subject Matter Expert to Abbott Manufacturing sites worldwide as subject Matter Expert (SME) for identifying Quality Systems Gaps and challenges related to Cleanrooms for aseptic manufacturing, Environmental Monitoring, Product Sterilization Process control, Product Sterility Assurance, Materials Control and Laboratory Controls.
- Provided Corporate Quality & Regulatory leadership and support to teh Pharmaceutical, Medical Device, Diagnostic and Nutritional facilities during significant Quality events, Product Failures, & performed Root Cause Investigation and Mitigation planning.
- Performed of Engineering, Maintenance, Laboratory and Manufacturing staff on Cleanrooms, Aseptic Manufacturing, Building and facility design, Environmental Monitoring, Sterilization processes and Sterility Assurance.
Confidential, Rochester, NY
Sr. Manager Quality Assurance
Responsibilities:
- Managed Contract Manufacturing of more than 1000 Drug, OTC, Consumer Health/Personal care and Nutritional Products Manufactured at 38 CMO Sites in North America and Overseas and Managed Product Release for Commercial distribution.
- Managed GMP compliance during product Development, Tech Transfer, Validations, Commercial Manufacturing, Quality Control Testing and Product Distribution from Bausch and CMO sites.
- Performed GMP Assessment/Audits of teh Contract Manufacturing Sites for Compliance Performance Management, Supplier Risk Management, Product Quality trending, Complaint Management, Documentation Control, Strategic Communications and Quality Agreement process.
- Managed a team for Finished Product Release of up to 200 batches per month as per supply chain demand for Commercial Distribution
- Lead teh teams for Root Cause Analysis & CAPA management, on product Failure and significant product quality trends and Managed Quality Performance issues of Multiple products in Product Life Cycle Management projects
- Hosted FDA, and other Regulatory Inspections, Customer Audits, Prepared & Executed CAPA plan, and communicated wif Regulatory agencies.
Confidential, Rochester, NY
Manager R & D Quality Assurance
Responsibilities:
- Expertly provided Quality leadership in development, design, implementation and valuation of quality systems and standards for new products during product development life cycle and ensure GXP compliance of teh entire development cycle through to drug approval.
- Spearhead multiple product development projects as a Quality Lead embedded in core project and CMC team environment, & establish Quality strategies, standards, specifications, and validation plans,
- Trained project teams on risk management, GMPs, GLP, and GCP, to ensure compliance wif global criteria while accomplishing quality objectives.
- Skillfully performed review of IND’s/NDA’s/BLA’s as subject matter expert and guide and advise CMC teams through teh drug development regulatory process and submissions.
- Proficiently directed teh Chemical Development of teh Drug substance, formulation development, manufacturing process, scale up, tech transfer and process and analytical method validation.
- Executed GMP compliance audits at various sites, TEMPeffectively assess quality systems and manufacturing controls, and accomplish pre-approval inspection readiness and direct teh pre-approval inspection strategy.
- Skillfully drove teh quality risk management program for new drug products and established design, process and usability risk assessment on new products.
- Implemented due diligence site audits proficiently exploring teh acquisition of new drug compounds, products and site selection of CMO, CRO and CLO.
- Managed Manufacturing, Clinical Packaging and quality control release of Investigational Drug for clinical evaluation Implement KPI and quality performance metrics for R&D and manufacturing sites.
- Performed, as a co-chair for teh global specifications committee and expertly approved, Components, finished product and API specifications for regulatory submissions.
- Directed processes wifin R&D Microbiology, Sterilization services, Analytical Method Development, Stability Testing, global packaging and labeling, and development process engineering (DPE) ensuring Compliance wif industry standards.
- Established Partnership wif Sourcing and Procurement for supplier selection and Qualification and performed supplier audits
- Drove quality change management, CAPA management and non-conformance management programs, and lead Root-cause investigations.
Confidential, Rochester, NY
Manager Global Quality Systems Design
Responsibilities:
- Provided leadership at a global platform, in Quality Transformation of Quality Management system originally designed as per 21 CFRs part 820 Medical Device GMP’s to comply wif Pharmaceutical GMP’s per 21 CFR 210 & 211. revised and established new policies, procedures and tools, trained teh staff and monitored GMP Compliance performance.
- As global quality leader in R&D team environment, provided strategic direction to teh project team, efficiently managed GMP compliance throughout product development and technology transfer, resulting in successful product launches wif no significant Quality event post launch, for more than 20 products launched.
- Managed GLP compliance program for multiple pre-clinical studies during early phase Pharmaceutical Development at a Global R & D center
- Provided GCP support for Dozens of Phase 1-4 Clinical trials, for multiple dosage forms, by Performing GCP audits of teh Investigator’s sites, CRO’s, GMP Manufacturing and QA release of teh investigation materials.
- Executed Quality tools, such as DFM, DFSS, QBD, DOE, SPC, cPK and pPK principals and Industry best practices during Formulation development, Specifications development, Process engineering and scale up.
- Provided QA input in establishing process range, defining Critical Process parameters, Process controls, In-process sampling strategies and process specifications, executing Process Validation, and creating batch manufacturing Instructions.
- Skillfully drove product and process risk management (FMEA) program for New Drugs in pipeline In R & D as per ICH Q9 and ISO 13489.
- Lead root cause investigations, deviation, OOS investigations and expertly controlled teh change management Activities during Product development.
- Managed Supplier QA program for Pharma R & D, performed supplier audits, established/negotiated Quality Agreements wif suppliers of key product components and swiftly identified and resolved quality issues
- Directed Microbiology R & D and QC laboratory personnel and efficiently oversaw operations TEMPeffecting quality control for teh testing and release of raw materials including in-process, bulk and finished products, packaging components and utilities samples.
Confidential
Quality Control Lab Supervisor
Responsibilities:
- Hired, Trained, Developed, managed and Directed laboratory personnel and efficiently oversaw operations TEMPeffecting quality control for teh testing and release of raw materials including in-process, bulk and finished products, packaging components and utilities samples.
- Expertly accomplished operational efficiency, regulatory and environmental health and safety compliance by skillfully and managing teh cross and ongoing rotation of activities among staff.
- Successfully managed environmental Monitoring Program and Environmental Non-conformance issues for a large Aseptic Manufacturing facility.
- Established a Sample tracking process in teh lab for raw materials, packaging materials, stability samples, in-process and Finished product samples and Environmental Monitoring samples for supply chain and efficiently drove finished product release for commercial production on SAP system.
- Oversaw teh technology transfer of products, process validation and facility engineering systems qualifications and provided leadership and technical support in Quality related issues.
- Spearheaded CQI projects, acquired sponsorship, established KPIs, achieved targets and compliance and TEMPeffectively drove projects while ensuring a culture of continuous quality improvement.
Confidential
Quality Assurance / Quality Control Manager
Responsibilities:
- Proficiently directed all activities wifin Quality Assurance, Quality Control Microbiology, Analytical Chemistry and Tissue Culture Labs and TEMPeffectively streamlined resources for sampling, testing and release of biological materials, product samples, raw materials, components and environmental and water samples.
- Directed teh stability program for products and successfully drove teh release of completed products for routine commercial distribution.
- Oversaw both internal and external compliance audits for various regulatory agencies including TTP, FDA, and USDA and expertly developed and implemented corrective actions as a result of audit observations.
- TEMPEffected an uninterrupted supply chain by ensuring contract manufacturing sites adhere to quality and technical terms.
- Skillfully oversaw teh quality control database by efficiently reviewing non-conformities, out of specification reports, material exception reports, environmental non-compliance reports (ENCRs) for clean rooms, and teh GMP-compliance database.
- Ensured teh efficient production and quality control of equipment and processes by driving teh site validation master strategy.
Confidential
Supervisor Quality Control Microbiology Lab
Responsibilities:
- Managed a large Quality Control microbiology/ Sterility Testing laboratory for Vaccine products
- Built a strong qualified team, by hiring teh competent lab staff, and Qualification program in alignment wif teh job description, streamlined work flow, performed Capacity planning, priority setting, and scheduling daily activities of QC release of materials for on-time product release.
- Enhanced Quality performance by implementing new technology in teh laboratory such as Isolator system for teh sterility testing, improved cGMP Compliance and TEMPeffective environmental monitoring program and aligned test methods and procedures wif global regulatory and industry standards.
- Reduced cycle time for QC testing & Release of commercial batches and Managed on-time release of teh raw materials, in-process, final bulk and finished products.
- Managed site environmental monitoring program of teh sterile manufacturing suites, managed on time sampling for a 24 hours facility, negotiated environmental issues wif Engineering and Production staff, helped redesign or modify teh facility/process flow which helped significant reduction in teh rate of Environmental Non-Conformance rate and improved teh trends.
- Conducted Aseptic behavior and clean room management for teh Quality, Production and Engineering staff.