OSI
Manager, Quality Systems
OSI, Boston, Massachusetts, us, 02298
Manager, Quality SystemsPosition Summary
The Manager Quality Systems will further develop and maintain the quality management systems supporting clinical trial activities within PepGen. Routine activities include development and maintenance of supplier management programs, including qualification assessments, auditing, quality agreements, and supplier list. The position requires excellent written and verbal communication skills with internal and external customers, peers, and managers. The Manager ensures continued compliance with FDA and other applicable regulations.ResponsibilitiesFurther development and management of PepGen’s Supplier qualification and QA oversight programs and proceduresMaintain Supplier Database and Approved Supplier ListOversee the Supplier Audit ScheduleSchedule and Perform Quality Audits of GCP, GLP and GMP vendorsConduct quality assessments of GMP, GCP and GLP Vendors systemsEvaluate, track and maintain quality agreements as per internal procedureEstablish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulationsParticipate in Health Authority inspectionsReview Quality Systems as needed including Deviations, CAPAs and Change ControlsConduct Risk Assessment review meetings as neededReview and assess External Change NotificationsCommunicate with CMOs, CROs, and Contract Laboratories, as appropriateRequirementsBachelor’s in Science, Engineering or a related discipline is requiredMinimum of 8 years of relevant work experience in a pharmaceutical/biotech environmentGCP/GMP/GLP quality assurance experience in the pharmaceutical or biotechnology industryUnderstanding of GMP regulatory requirements and implementation (FDA, ICH, EMA, etc.)Technical writing or investigation writing experienceStrong aptitude with Microsoft Office applications Word and Excel.Veeva experience preferred.Strong interpersonal and communication skills (written and verbal), team player, and flexible without compromising qualityStrong organizational skillsAbility to work independently and follow up on pending actions without being promptedPrevious supervisory experience preferred.About PepGenWe are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts. To learn more, please inquire at the link below, check out our website or follow us on Twitter and LinkedIn.EEO StatementPepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.Note:
This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week. This job will require additional days in the office as business needs dictate.Recruitment & Staffing AgenciesPepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
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The Manager Quality Systems will further develop and maintain the quality management systems supporting clinical trial activities within PepGen. Routine activities include development and maintenance of supplier management programs, including qualification assessments, auditing, quality agreements, and supplier list. The position requires excellent written and verbal communication skills with internal and external customers, peers, and managers. The Manager ensures continued compliance with FDA and other applicable regulations.ResponsibilitiesFurther development and management of PepGen’s Supplier qualification and QA oversight programs and proceduresMaintain Supplier Database and Approved Supplier ListOversee the Supplier Audit ScheduleSchedule and Perform Quality Audits of GCP, GLP and GMP vendorsConduct quality assessments of GMP, GCP and GLP Vendors systemsEvaluate, track and maintain quality agreements as per internal procedureEstablish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulationsParticipate in Health Authority inspectionsReview Quality Systems as needed including Deviations, CAPAs and Change ControlsConduct Risk Assessment review meetings as neededReview and assess External Change NotificationsCommunicate with CMOs, CROs, and Contract Laboratories, as appropriateRequirementsBachelor’s in Science, Engineering or a related discipline is requiredMinimum of 8 years of relevant work experience in a pharmaceutical/biotech environmentGCP/GMP/GLP quality assurance experience in the pharmaceutical or biotechnology industryUnderstanding of GMP regulatory requirements and implementation (FDA, ICH, EMA, etc.)Technical writing or investigation writing experienceStrong aptitude with Microsoft Office applications Word and Excel.Veeva experience preferred.Strong interpersonal and communication skills (written and verbal), team player, and flexible without compromising qualityStrong organizational skillsAbility to work independently and follow up on pending actions without being promptedPrevious supervisory experience preferred.About PepGenWe are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts. To learn more, please inquire at the link below, check out our website or follow us on Twitter and LinkedIn.EEO StatementPepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.Note:
This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week. This job will require additional days in the office as business needs dictate.Recruitment & Staffing AgenciesPepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
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