MSD Malaysia
Sr. Specialist External Quality (m/f/d)
MSD Malaysia, Rahway, New Jersey, us, 07065
Sr. Specialist External Quality (m/f/d)
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.The Product Quality Manager (PQM) is the Sr. Specialist within External Quality responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements. Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners (EP/ExP’s) manufacture and release of (Vaccine or Biologic Drug Substances and/or Drug products) by means of risk-based quality oversight and on-site supervision, as appropriate.The PQM will work within the Focus Factory Team to support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner, manufacturing process complexity.Primary Activities may include, but are not limited to the following:Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records.Manage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.Provide support for audits of EP/ExP by ourselves and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.Conduct routine and solve complex analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly.Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.Track and monitor operational and quality performance of the external manufacturer/partner and work with suppliers to develop CAPA plans.Assist in the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration, responsible for shipment under quarantine.Support routine process validation; review and approve validation reports/tech transfer.Prepare pre-PAI assessments, support document requests for regulatory filings and post-approval changes.Support EP/ExP for permanent Inspection Readiness (PIR).Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.Qualifications:Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.Ability to solve complex problems; takes a new perspective using existing solutions.Works independently, receives minimal guidance.Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME.May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.Explains difficult issues and works to build alignment around a complex situation.Accountable for a medium project with minimal resource requirements, risk and/or complexity.Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.Communicates easily in English both verbally and in writing.Strong knowledge of External Manufacturing management, supply chain, and operations.Lean Six Sigma / our Product ion Systems training.Preferred Experience and Skills:Direct experience with managing external partners.Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience.Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs).Familiarity with analytical assays for sterile vaccine/biologic drug product.Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ).Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards.Quality Risk Management (QRM) Experience.This position will report to the Quality Director or Associate Director, External Quality, for general advice and instruction concerning project, but functions independently and the position is based in Europe.THE COMPANYOur company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.
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Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.The Product Quality Manager (PQM) is the Sr. Specialist within External Quality responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements. Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners (EP/ExP’s) manufacture and release of (Vaccine or Biologic Drug Substances and/or Drug products) by means of risk-based quality oversight and on-site supervision, as appropriate.The PQM will work within the Focus Factory Team to support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner, manufacturing process complexity.Primary Activities may include, but are not limited to the following:Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records.Manage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.Provide support for audits of EP/ExP by ourselves and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.Conduct routine and solve complex analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly.Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.Track and monitor operational and quality performance of the external manufacturer/partner and work with suppliers to develop CAPA plans.Assist in the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration, responsible for shipment under quarantine.Support routine process validation; review and approve validation reports/tech transfer.Prepare pre-PAI assessments, support document requests for regulatory filings and post-approval changes.Support EP/ExP for permanent Inspection Readiness (PIR).Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.Qualifications:Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.Ability to solve complex problems; takes a new perspective using existing solutions.Works independently, receives minimal guidance.Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME.May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.Explains difficult issues and works to build alignment around a complex situation.Accountable for a medium project with minimal resource requirements, risk and/or complexity.Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.Communicates easily in English both verbally and in writing.Strong knowledge of External Manufacturing management, supply chain, and operations.Lean Six Sigma / our Product ion Systems training.Preferred Experience and Skills:Direct experience with managing external partners.Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience.Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs).Familiarity with analytical assays for sterile vaccine/biologic drug product.Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ).Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards.Quality Risk Management (QRM) Experience.This position will report to the Quality Director or Associate Director, External Quality, for general advice and instruction concerning project, but functions independently and the position is based in Europe.THE COMPANYOur company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland.
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