Director, Quality Operations

3 weeks ago

Cambridge, United States Sarepta Therapeutics Full time

The Director will be responsible for the program level QA oversight of clinical studies. This position will be a core member of the Clinical Trial team and provide Clinical Trial team support and promote collaboration to ensure all clinical trial activities and outcomes are compliant with FDA Regulations, ICH guidelines, and applicable international standards.. This position reports to the Senior Director, Quality Operations within Research & Clinical Development Quality Assurance (R&CD QA).

Primary Responsibilities Include:

- Proactively provides GXP QA support and guidance to the Clinical Trial teams based on analysis and interpretation of GXP regulations to assure best Clinical/QA practices
- Assist Clinical Trial teams in the development of CAPA plans and investigations in response to quality issues, audits, and inspections
- Review clinical trial and regulatory submission documentation for completeness and adherence to regulatory requirements
- Develop and maintain the study specific audit plan for assigned studies. Assist with investigator site audit selection, audit preparation, and provide support for audit responses as needed
- Provide surveillance of upcoming regulations and regulatory authority interpretations, share with R&CD QA staff, Clinical Trial teams, and leadership to inform R&CD QA audit program development and direct compliance initiatives
- Manage the resolution of compliance issues or delegate to other qualified persons identified at clinical vendors and clinical sites and provide assessment of the impact of any deficiencies
- Participate in the implementation of GXP compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies
- Develop and implement process improvements to internal programs as indicated by issue management, audit observations, new regulations, guidance documents, and industry standards
- Assist cross-functional teams as necessary with the development, review and implementation of SOPs
- Act as primary point of contact for stakeholders regarding R&CD QA, providing comprehensive information on processes and quality measures
- Provides training sessions on topics related to GCP quality and global regulations
- Support Inspection Preparation and Inspection Readiness activities
- Perform other related duties and special projects as needed

Desired Education and Skills:

- Bachelor’s degree in the Life Sciences with 15+ years in pharmaceutical or biotech drug development. Advanced degree preferred.
- Minimum 10 years of experience in Clinical QA, including both external and internal auditing.
- Demonstrated experience working with Clinical Trial teams
- Extensive experience with global clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guidelines, FDA Regulations and EU Requirements
- Previous experience supporting Regulatory Authority Inspections
- Experience in development and oversight of Quality Management Systems
- Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop good working relationship with cross functional personnel at all levels

LI-Hybrid

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 $180,000 - $225,000 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.

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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