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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, International QA
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Description
The Position:
The successful candidate will be a highly motivated, independent, curious and experient Quality Professional that will support the Sr. Director QA Internal GMP / GDP in the ex-USA QA expansion, while also ensuring that the ex-USA QA organization receives the right support from Sarepta Corporate QA.
Key focus areas and responsibilities for this position include: processes & procedures development and improvement to support regions & countries, Quality Technical Agreements with Suppliers / Vendors / Sarepta Affiliates, onboarding of new members of the QA team, development of specific GMP or GDP training, support / facilitate or operationalize specific needs from the regions / countries at Corporate Level, participate into specific projects, generate Key Performance Indicator Metric Reports.
Primary responsibilities include but are not limited to:
* Development and improvement of processes and procedures to support QA needs from regions & countries
* Ensure that Corporate Procedures and Standards are properly deployed into the regions & countries
* Ensure GMP / GDP training programs are implemented and maintained
* Manage deviations, corrective / preventive actions, complaints and change controls
* Support or conduct specific investigations or review results provided by Regional, Country QA or other Functions (When applicable)
* Escalate real and potential issues to the Senior Management
* Develop a robust on-boarding program for new Regional QA and Country Quality Heads
* Gather, maintain and communicate Key Performance Indicators (KQI`s)
* Support projects (as assigned)
* Support Health Authority Inspections (when assigned)
* Support in negotiation of relevant agreements including but not limited to Master Services Agreement (MSA) and Quality Technical Agreement (QTA) for vendors, wholesalers, etc.
* Support eventual product recalls from a Global Level perspective in collaboration with Regional and Country QA, as well as Supply Chain.
* Work in partnership with other departments / functions to ensure proper support to countries in regards to product launches & achievement of commercial timelines.
Education, Experience and Skill requirements:
* University degree in Chemistry, Pharmacy, Biology or other related scientific discipline
* 10+ years of experience within Pharmaceutical Quality, bio-tech products or gene therapy. Commercial QA is a plus.
* 4+ years of management / leadership experience
* Experience interfacing / working with regulatory bodies. International markets a plus.
* Strong understanding of cGMP/cGDP regulations, guidelines and compliance requirements (FDA, EU, JAPAN, ANVISA). Others a plus.
* Excellent verbal, written, interpersonal communication skills
* Ability to work collaboratively and effectively with internal and external teams and to build relationships
* Proven ability to plan, implement and achieve significant complex goals and objectives with flexibility
* Demonstrated exercise of sound judgment, discretion, and business decisions
* Ability to travel domestically and internationally
* Fluent in English (Writing / Reading / Speaking). Additional language fluency a plus.
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:
49245774
* Posted:
June 28, 2019
* Position Title:
Associate Director, International QA
* 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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* University degree in Chemistry, Pharmacy, Biology or other related scientific discipline * 10+ years of experience within Pharmaceutical Quality, bio-tech products or gene therapy. Commercial QA is a plus. * 4+ years of management / leadership experience * Experience interfacing / working with regulatory bodies. International markets a plus. * Strong understanding of cGMP/cGDP regulations, guidelines and compliance requirements (FDA, EU, JAPAN, ANVISA). Others a plus. * Excellent verbal, written, interpersonal communication skills * Ability to work collaboratively and effectively with internal and external teams and to build relationships * Proven ability to plan, implement and achieve significant complex goals and objectives with flexibility * Demonstrated exercise of sound judgment, discretion, and business decisions * Ability to travel domestically and internationally * Fluent in English (Writing / Reading / Speaking). Additional language fluency a plus. Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.


Associated topics: automation, prevent, quality, quality assurance, quality assurance analyst, quality assurance engineer, software quality, software quality assurance, test engineer, tester

* 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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