• Sarepta Therapeutics
  • $184,730.00 -184,730.00/year*
  • Newton Center , MA
  • Executive Management
  • Full-Time
  • 101 Olde Field Rd

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 www.sarepta.com.

Sarepta Therapeutics
Associate Director, IT Validation
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Description
The Position:
The Associate Director will be responsible for ensuring GxP computerized systems are validated and controlled in compliance with local (e.g. 21 CFRT parts 11, 58, 210, 211) and international (e.g. Eudralex and ICH Q7) guidelines. This individual will lead the qualification efforts in collaboration with IT using the SDLC of enterprise and server-based applications supporting GxP operations. Additionally, the individual will be responsible for providing Quality oversight of laboratory systems and instrumentation qualification efforts.
Primary Responsibilities include:
* Providing regulatory guidance for CSV policies and procedures for validation and data integrity.
* Developing validation strategies for new or modified computerized systems.
* Act as the Data Integrity (DI), CSV, and regulatory compliance subject matter expert (SME).
* Facilitate the development and implementation of DI and CSV policies and procedures.
* Works with system / business owners on DI and CSV assessment, qualifications and testing.
* Review and approval of SDLC documentation including, but not limited to, SOPs, qualification protocols, gap assessments, risk assessments, impact assessments, user requirements, functional and configuration specifications, requirements and traceability matrices
* Oversee CSV related change controls, deviations and investigations.
* Uses risk management principles for qualification and remediation efforts.
* Oversee the periodic qualification review and maintenance of computerized systems.
* Lead and represent QA in multi-department project teams for CSV projects.
* Provide audit support for CSV both locally and at CMOs/CTLs.
* Serves as an SME of investigations and corrective and preventative action (CAPA) recommendations
* Interfaces with Regulatory agencies as required representing Sarepta to authorities and regulatory inspectorates in matters relating to CSV
* Provide regular updates directly to Management
Education and Skills Requirements:
* 8+ years of direct, relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience strongly preferred
* Direct experience working in CSV using FDA, ICH and GAMP guidance.
* Knowledge and experience in CSV in highly regulated manufacturing environments
* Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally
* Knowledge of biologics/gene therapy, chemical synthesis processes, analytical instrumentation desirable
* Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
* Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
* Able to exercise judgment and independently determine and take appropriate action where precedent may not exist
* Demonstrates knowledge of industry best practices and trends
* Excellent verbal, written, and interpersonal communication skills are required
* Experience leading a team
* Prior QA experience desirable
* Travel required, up to 25% domestic and international.
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, 01810, United States
* Job ID: 47833762
* Posted: April 11, 2019
* Position Title: Associate Director, IT Validation
* 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 www.sarepta.com.
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* 8+ years of direct, relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience strongly preferred * Direct experience working in CSV using FDA, ICH and GAMP guidance. * Knowledge and experience in CSV in highly regulated manufacturing environments * Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally * Knowledge of biologics/gene therapy, chemical synthesis processes, analytical instrumentation desirable * Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories * Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness * Able to exercise judgment and independently determine and take appropriate action where precedent may not exist * Demonstrates knowledge of industry best practices and trends * Excellent verbal, written, and interpersonal communication skills are required * Experience leading a team * Prior QA experience desirable * Travel required, up to 25% domestic and international. Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.


Associated topics: agile, c++, c#, db2, etl, linux, machine learning, sdlc, sql, sw

* 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.

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