Sarepta Therapeutics
Manager, Quality Assurance Auditing
Sarepta Therapeutics, Andover, Massachusetts, us, 05544
Why Sarepta? Why Now?The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.What Sarepta OffersAt Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:Physical and Emotional WellnessFinancial WellnessSupport for CaregiversFor a full list of our comprehensive benefits, see our website:
https://www.sarepta.com/join-usThe Importance of the RoleThe Manager, QA Auditing will be responsible for leading domestic and international Corporate Compliance Audits, including internal audits of Sarepta GxP facilities and external audits in accordance with Sarepta policies and procedures. He/she will proactively identify compliance risks and communicate to Sarepta leadership. He/she will manage Sarepta's Corporate GxP Auditing Program to include oversight of audit programs established for cGMP and GDP (as applicable EU Distribution).The Opportunity to Make a DifferenceConduct internal audits of Sarepta GxP sites and facilities. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.Lead Inspection Readiness Activities at Sarepta facilities and participate in Regulatory Inspections and Partner Audits.Manage gap assessment audits and Regulatory readiness inspections at Sarepta facilities as needed.Conduct external audits of Sarepta approved vendors including Contract Manufacturers, APIs, Drug Product, Primary and Secondary Packaging, Contract Laboratories, 3PL and transport vendors. Develop audit plan, conduct quality audit, prepare audit reports and communicate and escalate findings, including compliance risk. Recommends approval or disapproval of vendors based on compliance assessment.Review and evaluate vendors audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet quality requirements.Assist in the maintenance of the annual internal and external audit schedules as requested by management.Prepare metrics and reports of auditing activities and submit for Management Review.Other Activities:Manage Sarepta's Approved Vendor Management program as applicable to all current and new vendors. Perform vendor performance report including risk assessment.Manage the Vendor Change Notification program.Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks.Manage auditing files, records, reports, licenses and certificates associated with approved vendor program.Maintain audit files and databases to ensure all documentation is current.Assumes additional duties and responsibilities as assigned.More about YouBachelor's Degree required in a scientific discipline.Minimum 7 years' experience in a regulated industry required; in a Quality Auditing role preferred.Other requirements include: Excellent organizational skills; ability to work independently and in team environments.Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.Understanding of GMP/GDP compliance requirements; understanding of FDA and Global GMP Quality Requirements.Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.Must demonstrate effective communication skills and technical writing ability.Must be able to travel domestically and/or internationally 10% of the time.What Now?We're always looking for solution-oriented, critical thinkers.So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.#LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.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.
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https://www.sarepta.com/join-usThe Importance of the RoleThe Manager, QA Auditing will be responsible for leading domestic and international Corporate Compliance Audits, including internal audits of Sarepta GxP facilities and external audits in accordance with Sarepta policies and procedures. He/she will proactively identify compliance risks and communicate to Sarepta leadership. He/she will manage Sarepta's Corporate GxP Auditing Program to include oversight of audit programs established for cGMP and GDP (as applicable EU Distribution).The Opportunity to Make a DifferenceConduct internal audits of Sarepta GxP sites and facilities. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.Lead Inspection Readiness Activities at Sarepta facilities and participate in Regulatory Inspections and Partner Audits.Manage gap assessment audits and Regulatory readiness inspections at Sarepta facilities as needed.Conduct external audits of Sarepta approved vendors including Contract Manufacturers, APIs, Drug Product, Primary and Secondary Packaging, Contract Laboratories, 3PL and transport vendors. Develop audit plan, conduct quality audit, prepare audit reports and communicate and escalate findings, including compliance risk. Recommends approval or disapproval of vendors based on compliance assessment.Review and evaluate vendors audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet quality requirements.Assist in the maintenance of the annual internal and external audit schedules as requested by management.Prepare metrics and reports of auditing activities and submit for Management Review.Other Activities:Manage Sarepta's Approved Vendor Management program as applicable to all current and new vendors. Perform vendor performance report including risk assessment.Manage the Vendor Change Notification program.Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks.Manage auditing files, records, reports, licenses and certificates associated with approved vendor program.Maintain audit files and databases to ensure all documentation is current.Assumes additional duties and responsibilities as assigned.More about YouBachelor's Degree required in a scientific discipline.Minimum 7 years' experience in a regulated industry required; in a Quality Auditing role preferred.Other requirements include: Excellent organizational skills; ability to work independently and in team environments.Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.Understanding of GMP/GDP compliance requirements; understanding of FDA and Global GMP Quality Requirements.Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.Must demonstrate effective communication skills and technical writing ability.Must be able to travel domestically and/or internationally 10% of the time.What Now?We're always looking for solution-oriented, critical thinkers.So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.#LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.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.
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