Assistant Director, Quality Assurance - GMP Vendor Management

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, QUALITY ASSURANCE - GMP VENDOR MANAGEMENT

SUMMARY:

Seeking an experienced Assistant Director in Quality Assurance with strong knowledge and expertise in Vendor Management and Internal Audits.  The ideal candidate will have experience with Risk Assessments, Onsite/Remote/Questionnaire Audits, Deviations, CAPAs, Change Control and Quality Agreements.  Preference will be given to a candidate with a strong Quality Assurance, compliance and systems background, knowledge in Global Regulatory requirements (cGMP, ICH Q10, FDA, EMA).  Experience with Small Molecules, Biologics, Medical Devices and/or Combination Products is preferred.  In addition, excellent verbal and written communication, strong analytical, and problem-solving skills are required.  The individual must be a team player, maintains professionalism, and can work with cross-functional teams on high impact projects.   

RESPONSIBILITIES/ CORE COMPETENCIES: 

• Lead and execute Vendor Qualification processes in accordance with established risk-based model and ensure there is no interruption to the business.
• Strong knowledge and/or experience with planning, preparing, conducting and documenting cGMP Vendor and Internal Audits, including onsite, remote and questionnaire audits according to applicable Regulatory standards.
• Lead and manage Quality Agreement program. Initiate, negotiate, establish and periodically update quality agreements of new and existing GMP vendors.
• Track and lead management of New Vendor Requests received, including working with SMEs on risk assessment and scoring, and delivering to the business with no interruption to business timelines.
• Manage Vendor change notifications and assessments, and work with SMEs on assessments while ensuring adherence to vendor change timelines and internal/regulatory requirements.
• Experience with Discrepancy management (vendor/material/ service-related deviation investigations, CAPA development).
• Adheres to established standard lead times, key performing indicators and contributes to Quality metrics.
• Strong technical writing, critical thinking, problem solving, influencing, and intra-/ inter-company communication skills.
• Ability to work independently, is organized, can multi-task and adjust priorities in a dynamic environment.
• Collaborate or lead projects to drive continuous quality improvements and implement best practices.

REQUIREMENTS: 

• B.S. in Chemistry, Chemical Engineering, or related disciplines; advance degree preferred.
• 8 years in the Life Sciences industry with Quality Assurance experience and 5 years with Vendor Management experience is preferred
• Experience in Quality Assurance with emphasis on compliance and process improvement
• Working knowledge of regulations, such as domestic and international cGMPs
• Experience in problem solving, process improvement and negotiations
• Committed to delivering high quality results, overcoming challenges, focusing on what matters
• Continuously looking for opportunities to learn, build skills and share learnings both internally and externally
• Travel up to 15% may be required

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003691

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 $104,764 to $145,330

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

Salary : $104,764 - $145,330