Antares Pharma
Associate Director, External Quality Assurance
Antares Pharma, San Diego, California, United States, 92189
Associate Director, External Quality AssuranceWelcome to an inspired career.At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. That's why we need you to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.Join us as an
Associate Director, External Quality Assurance
and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives.How you will make an impactAs the Associate Director, External Quality Assurance, you will lead Quality Assurance oversight of Halozyme's Contract Manufacturing Organizations (CMO) producing Drug Substance/Bulk Enzyme and collaborate with other elements of the Halozyme organization to ensure the highest quality materials for internal and partner use.In this role, you'll have the opportunity to:Ensure CMO compliance with all applicable cGMP regulations, batch records, validated processes, QC testing requirements, and data integrity.Review Annual Product Quality reporting for products within scope.Lead quality technical aspects of modifications to, and improvements of, existing products and processes and the release of new products.Support QA lot disposition with technical data review, review of CMO method execution and transfer, supporting QC and QA technical problem solving, and documentation to facilitate internal and external product programs.Work with appropriate subject matter authorities to provide support to CMOs in QA-related investigations and analytical method issues.Support the administration of the Change Control Quality System including the ability to:
Generate, critically assess, and approve change controls in accordance with quality agreement requirements.Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements.Develop and execute change control implementation plans.
Oversight of internal Quality Systems such as CAPA, complaints management, and participating in Management Review.Participate in and lead CDMO audits and support partner audits of Halozyme.Support Quality aspects of new product scale-up, process improvement, technology transfer and process-validation activities.Lead all activities related to providing required documentation, review and revision of procedures, specifications, forms, and supporting regulatory filing documents.To succeed in this role, you'll need:BS degree in Analytical Chemistry, Biochemistry, Engineering or related fields with at least 12 years of industry experience (a combination of education and experience may be considered).A solid background in analytical technologies for large and small molecule products and previous experience working in Quality/CMC for pharmaceutical, medical device or diagnostic industry.Excellent knowledge of cGMPs or equivalent regulations and ability to interpret and relate Quality standards for implementation and review.Experience in project management and/or project leadership in a complex matrix environment is required.Ability to work closely with internal departments, partners and CMOs including senior management on significant matters concerning projects and commitments.Previous experience in working with external parties (CMOs, Contract Labs) is preferred.Ability to travel to support audits or site management activities (up to approximately 15%) both domestically and internationally.In return, we offer you:Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives.Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.Accessibility and Reasonable Accommodations:Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at hrbox@halozyme.com.
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Associate Director, External Quality Assurance
and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives.How you will make an impactAs the Associate Director, External Quality Assurance, you will lead Quality Assurance oversight of Halozyme's Contract Manufacturing Organizations (CMO) producing Drug Substance/Bulk Enzyme and collaborate with other elements of the Halozyme organization to ensure the highest quality materials for internal and partner use.In this role, you'll have the opportunity to:Ensure CMO compliance with all applicable cGMP regulations, batch records, validated processes, QC testing requirements, and data integrity.Review Annual Product Quality reporting for products within scope.Lead quality technical aspects of modifications to, and improvements of, existing products and processes and the release of new products.Support QA lot disposition with technical data review, review of CMO method execution and transfer, supporting QC and QA technical problem solving, and documentation to facilitate internal and external product programs.Work with appropriate subject matter authorities to provide support to CMOs in QA-related investigations and analytical method issues.Support the administration of the Change Control Quality System including the ability to:
Generate, critically assess, and approve change controls in accordance with quality agreement requirements.Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements.Develop and execute change control implementation plans.
Oversight of internal Quality Systems such as CAPA, complaints management, and participating in Management Review.Participate in and lead CDMO audits and support partner audits of Halozyme.Support Quality aspects of new product scale-up, process improvement, technology transfer and process-validation activities.Lead all activities related to providing required documentation, review and revision of procedures, specifications, forms, and supporting regulatory filing documents.To succeed in this role, you'll need:BS degree in Analytical Chemistry, Biochemistry, Engineering or related fields with at least 12 years of industry experience (a combination of education and experience may be considered).A solid background in analytical technologies for large and small molecule products and previous experience working in Quality/CMC for pharmaceutical, medical device or diagnostic industry.Excellent knowledge of cGMPs or equivalent regulations and ability to interpret and relate Quality standards for implementation and review.Experience in project management and/or project leadership in a complex matrix environment is required.Ability to work closely with internal departments, partners and CMOs including senior management on significant matters concerning projects and commitments.Previous experience in working with external parties (CMOs, Contract Labs) is preferred.Ability to travel to support audits or site management activities (up to approximately 15%) both domestically and internationally.In return, we offer you:Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives.Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.Accessibility and Reasonable Accommodations:Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at hrbox@halozyme.com.
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