Tbwa Chiat/Day Inc
Senior Manager/Associate Director, QA Operations Somerville, Massachusetts, Unit
Tbwa Chiat/Day Inc, Somerville, Massachusetts, us, 02145
Senior Manager/Associate Director, QA Operations
Somerville, Massachusetts, United States Qualifications:
BA/BS in scientific discipline and 12+ years of demonstrated GMP Quality experience in the pharmaceutical / biopharmaceutical industry; or MS degree and 10+ years of relevant experience Experienced with QA oversight of GMP manufacturing and Quality Control testing Responsibilities:
Executing QA on the floor support for in-house manufacturing activities Reviewing and approving master and executed batch records Reviewing and approving method qualification protocols and reports, test methods, certificates of analyses and product stability related activities Overseeing GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; providing oversight of appropriate CAPAs associated with deviations and investigations Providing oversight for the documentation of internal changes Supporting timely batch release. Overseeing the review and approval of all GMP related documentation, and ensuring compliance with regulatory requirements Reviewing and approving internally authored documents- e.g. SOPs, work instructions, forms Participating in risk assessment activities associated with batch release About You:
You are a skilled individual who can independently lead internal QA Operational activity. As a member of the Quality Assurance team, you will provide Quality Assurance expertise and act as the subject matter expert for oversight for internal Manufacturing and QC activities. You enjoy being on-site to support site-related activities. You promote a safe work environment and drive continuous improvement activities and demonstrate appropriate escalation methods while troubleshooting. You are experienced in collaborating with cross-functional teams (including Manufacturing, Quality Control, Quality Systems, Materials Management, and Facilities). Company Summary:
Tessera Therapeutics is pioneering Gene Writing— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability. Equal Opportunity Employer:
Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. Apply for this job
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Somerville, Massachusetts, United States Qualifications:
BA/BS in scientific discipline and 12+ years of demonstrated GMP Quality experience in the pharmaceutical / biopharmaceutical industry; or MS degree and 10+ years of relevant experience Experienced with QA oversight of GMP manufacturing and Quality Control testing Responsibilities:
Executing QA on the floor support for in-house manufacturing activities Reviewing and approving master and executed batch records Reviewing and approving method qualification protocols and reports, test methods, certificates of analyses and product stability related activities Overseeing GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; providing oversight of appropriate CAPAs associated with deviations and investigations Providing oversight for the documentation of internal changes Supporting timely batch release. Overseeing the review and approval of all GMP related documentation, and ensuring compliance with regulatory requirements Reviewing and approving internally authored documents- e.g. SOPs, work instructions, forms Participating in risk assessment activities associated with batch release About You:
You are a skilled individual who can independently lead internal QA Operational activity. As a member of the Quality Assurance team, you will provide Quality Assurance expertise and act as the subject matter expert for oversight for internal Manufacturing and QC activities. You enjoy being on-site to support site-related activities. You promote a safe work environment and drive continuous improvement activities and demonstrate appropriate escalation methods while troubleshooting. You are experienced in collaborating with cross-functional teams (including Manufacturing, Quality Control, Quality Systems, Materials Management, and Facilities). Company Summary:
Tessera Therapeutics is pioneering Gene Writing— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability. Equal Opportunity Employer:
Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. Apply for this job
* indicates a required field
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