Assistant Director, Development Quality Assurance

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us.  We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.  Experience and contribute to our unique culture while you develop and expand your career!

ASSISTANT DIRECTOR, DEVELOPMENT QUALITY ASSURANCE

SUMMARY:

The Assistant Director, Development Quality Assurance (DQA), Quality Operations function supports QA activities for GCP/GLP/GVP. Development QA has oversight of GCP, GLP and GVP, and partners closely with GMP QA. This position focuses on supporting GCP, GLP, and GVP quality metrics, audit planning/strategy, quality system projects, vendor management program, and QA-led inspection activities (including mock).  

RESPONSIBILITIES: 

• Develops and manages GCP, GVP, and GLP audit and inspection metrics that measure trends in audit responses, audit/inspection corrective actions/preventive actions (CAPA)/quality events (QE), and inspection request/pre-inspection requests.
• Provides data analytic trends, forecasting, and analysis from GCP/GLP/GVP audit and inspection generated metrics and dashboards to identify gaps/risks and/or areas for process improvement.
• Develops and manages quality data and metrics for Quality Management Review (QMR) meetings.
• Coordinates/manages activities for QA-led global regulatory agency inspections, mock inspections and partner audits. Activities can include but are not limited to:
  • Performing quality checks (QC) or final formatting of inspection documents
  • Manages inspection templates and tools
  • Manages electronic system access and electronic inspection tools
  • Prepares/coordinates QA backroom activities
  • Performs and/or manages inspection requests aiding in request issuance and triaging, inspection request tracker maintenance, request tracking metrics, inspection documents/file reconciliation, and management of relevant shared file libraries
  • Response collation that includes providing guidance to SMEs on root cause analysis (RCA) formulation, CAPA plan development, and timely execution/implementation of inspection CAPA commitments
• Contributes to DQA process improvements and enhancements to audit and inspection toolkits.
• Supports Quality Operations partner in managing audit deliverables, audit schedule, inspection and pre-inspection activities tracking, and vendor management activities.
• Support and/or participate in DQA initiatives to ensure stakeholders and processes maintain compliance with GCP/GLP/GVP regulations or requirements.
• Partners with Vendor Management Team onboarding, maintaining, or deactivating GCP/GLP/GVP vendors.
• Supports with audit strategy/audit planning activities for all audit types under GCP/GLP/GVP remit.
• Participate and support Veeva Quality initiatives.
• Contributes to development of processes (SOPs/GDs) and/or participates in review of company processes.

REQUIREMENTS: 

• Bachelor’s degree with 8 years of relevant QA experience; or master’s degree with 6 years of relevant QA experience; or PhD with 3 years of relevant QA experience.
• Has knowledge/understanding of ICH E6 and GCP/GLP/GVP regulations.
• Strong knowledge of metrics and data analytics best practices as they relate to a clinical/PV QMS.
• Experience working with electronic systems in support of clinical trial activities and quality activities.
• Has strong understanding/knowledge working with Microsoft Excel or SmartSheet.
• Has experience with or willingness to learn and utilize metric dashboard tools (e.g., Power BI, Tableau, Scoro, Google Analytics, etc.) and has ability to automate dashboards where applicable.
• Has knowledge/understanding of RCA and CAPAs.
• Has knowledge/understanding of data required for audit planning/scheduling.
• Has knowledge/understanding of vendor management in support of audit planning/scheduling activities and budget implications.
• Willingness to cross-train and support Quality Operation activities as back-up.
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
• Experience participating in regulatory inspections (e.g., FDA, EMA, MHRA, etc.) and mock inspection readiness planning and execution.
• Strong GCP auditing skills desired. GLP/GVP auditing skills a plus.
• Good understanding of FDA regulations and ICH guidelines pertaining to drug development.
• Ability to work both independently and in a team setting.
• Outstanding communication skills (verbal and written).
• Ability to manage multiple projects in a fast-paced environment and pivot to support competing priorities.
• Excellent organizational skills and keen attention to detail.
• Ability to travel up to ~20-25%.
  
   

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003696

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded

The pay scale for this position is $133,724 to $162,231

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Salary : $133,724 - $162,231