Senior Director, Site Quality

Location
Durham, NC, US
Posted
Sep 24, 2020
Ref
5492
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Senior Director, Site Quality, is responsible for overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Global Quality Operations leadership team, the Senior Director represents the site on projects, providing strategic input and recommendations.

Responsibilities
  • Develops and leads an effective, efficient Quality team (both Quality Assurance and Quality Control) at the Novartis Gene Therapies operating site based.
  • Overseas and is accountable for all aspects of Quality Assurance and Quality Control for the site.
  • Overseas and is accountable for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations.
  • Develops and delivers a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes.
  • Oversees the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
  • Recommends corrective actions necessary to ensure conformity with quality specifications.
  • Creates and leads a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
  • Develops strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T).
  • Provides strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs).
  • Hires and trains a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations.
  • Participates in external vendor quality audit program.
  • Manages findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product.
  • Manages site inspection preparation, management and response process.
  • Selects manufacturing, testing, and distribution contract suppliers (support audits as needed).
  • Provide quality input during manufacturing runs at CMOs.
  • Ensures all stability studies are designed and executed to enable IND and BLA filings.
  • Designs and approves material compatibility experiments of finished goods components.
  • Develops budget and monitors expenditures.
  • Other related job duties as assigned.

Qualifications
  • S. degree in Science, Engineering or related field with 12 years' experience in quality based roles including experience in biopharmaceutical GMP cell culture, purification, aseptic fill/finish, and laboratory operations or Masters' with 10 years' of relevant experience or PHD with 8 years' relevant experience.
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • 5 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff.
  • Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
  • Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
  • Demonstrated ability as a strategic thinker.
  • Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational excellence.
  • Must be located at the site overseeing.
  • Six sigma training or practical experience a plus.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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