Senior Manager/Associate Director, Quality Assurance Operations

  • Sarepta Therapeutics
  • $108,380.00 - 167,060.00 / Year *
  • 130 E Washington St, North Attleboro, MA 02760
  • Full-Time



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Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit ., Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at . Sarepta Therapeutics Senior Manager/Associate Director, Quality Assurance Operations Apply Now * Print * Save * Share Description The Company: Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit . The Position: The Sr. Manager/Associate Director of Quality Assurance Operations will lead the quality operations (for clinical and commercial) related to CMOs. This includes contract manufacturing, contract labs, packaging/labeling, and warehouse/distribution. He/she will oversee the batch record review and product disposition process. The candidate will be responsible for development, implementation and management of a robust compliant Quality program for CMO oversight and product distribution. Primary Position Responsibilities Include: * Managing a small team of Quality Assurance Associates responsible for Batch Record Review and Lot Release * Tracking and reporting release metrics * Partnering with various user groups to facilitate Lot Release workflow processes * Providing general quality assurance support for the overall Quality System in place at Sarepta and at Sarepta's CMOs and CTLs * Owning CMO oversight including Manufacturing, CTL, Packaging/Labeling, Warehouse * Responsible for overseeing Vendor management program * Responsible for Deviations, Investigations, CAPAs, Change Controls * Partnering closely with the Quality organization, Technical Operations, Supply Chain and CMO sites to establish and maintain effective working relationships, assist in project time lines, technical transfers, and other duties as necessary Education and Skills Requirements: * Bachelor's Degree required; Bachelor's Degree or higher in a scientific discipline preferred * Minimum 10 - 12 years' experience in a regulated industry required; in a Quality Assurance Lot Release role preferred * Excellent organizational skills; ability to work independently and in team environments * Understanding of FDA GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices; and experience training personnel on document control systems and Quality Assurance concepts * Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required * Experience in working within document control systems is preferred * Experience with Electronic Document and Quality Management Systems preferred * Strong leadership and communication skills * Capable leader, able to influence the organization * Able to build relationships with various functional and business leaders in order to drive change in their areas * Self-motivated, ability to make independent and informed decisions * Knowledge of various system and product regulatory requirements (ICH / ISO / cGMP / etc) * Travel at a minimum of 10% mostly domestic Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Job Information * Location: Andover, Massachusetts, United States * Job ID: 47121617 * Posted: March 5, 2019 * Position Title: Senior Manager/Associate Director, Quality Assurance Operations * Company Name: Sarepta Therapeutics * Job Function: Quality Assurance * Entry Level: No About Sarepta Therapeutics Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at . More Jobs from Sarepta Therapeutics Jobs You May Like 19-041 Sarepta Therapeutics Andover, United States Associate Director/Director, Project Manager... Sarepta Therapeutics Andover, United States Technical Operations I, Drug Product Manufacturing Pfizer Inc Andover, United States Senior Associate Scientist, Novel Delivery... Pfizer Inc Andover, United States* Bachelor's Degree required; Bachelor's Degree or higher in a scientific discipline preferred * Minimum 10 - 12 years' experience in a regulated industry required; in a Quality Assurance Lot Release role preferred * Excellent organizational skills; ability to work independently and in team environments * Understanding of FDA GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices; and experience training personnel on document control systems and Quality Assurance concepts * Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required * Experience in working within document control systems is preferred * Experience with Electronic Document and Quality Management Systems preferred * Strong leadership and communication skills * Capable leader, able to influence the organization * Able to build relationships with various functional and business leaders in order to drive change in their areas * Self-motivated, ability to make independent and informed decisions * Knowledge of various system and product regulatory requirements (ICH / ISO / cGMP / etc) * Travel at a minimum of 10% mostly domestic Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.