Assistant Director, GxP Quality Systems (QA Vendor Management)

Company Overview

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’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology, and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and 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 that our success is a direct result of the exceptional talents 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, hybrid, and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

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

Summary

We are seeking an experienced Assistant Director with strong knowledge and expertise in Quality Systems, Vendor Management and External / Internal Audit Programs, with emphasis on Computer System Validation (CSV) and Data Integrity Audits. The ideal candidate will be highly motivated, detail-oriented, inquisitive and can proactively lead and be responsible for activities, assignments, and completing tasks in accordance with established expectations and timelines. This role is for an individual contributor reporting to the Director, GxP Quality Systems – Vendor Management.

Primary responsibilities will entail leading the Internal Audit Program and auditing vendors (domestically and internationally, as assigned). Furthermore, the scope of responsibilities includes end-to-end vendor management (i.e., vendor on-boarding and off-boarding, qualification, auditing, performance monitoring, and measurement/metrics), working with multi-disciplinary and cross-functional teams regarding Change Management, Deviation & CAPA Management, Material Qualification, Quality Agreement Management, and Risk Management.

Preference will be given to candidates possessing strong compliance and Quality Systems experience (including QA applications), knowledge of GMP regulatory requirements (e.g., FDA, Eudralex, Health Canada, ICH, MHRA, MHLW), and hands-on CSV execution and / or auditing experience. Experience with small molecules, biologics, medical devices and / or combination products will be considered accordingly.

Candidates must also have excellent verbal and written communication skills, and strong analytical and problem-solving abilities. Furthermore, the candidate must be able to work in a dynamic and fast-paced environment, be a team player, maintain professionalism, and be able to work with multi-disciplinary, cross-functional teams on high impact projects delivering quality results in accordance with agreed upon timelines. This role is based at our company headquarters in Carlsbad, CA, and may be fully remote, however, an on-site or hybrid presence is highly preferred.

Responsibilities

• Lead and execute Internal Audit Program in accordance with established procedures and through application of risk management to always ensure site compliance and inspection readiness.
• Independently lead and execute GMP Vendor and Internal Audits (including onsite, remote and questionnaire audits) in accordance with applicable domestic or international regulatory requirements and industry best practices.
• Lead and manage Quality Agreement Program. Initiate, negotiate, establish, and periodically update new and existing agreements with GMP vendors.
• Manage Vendor Change Notifications collaborating with customers / stakeholder regarding impact and quality assessments and ensuring adherence to vendor change timelines and internal / regulatory requirements, as applicable.
• Lead investigations and/or analyze and trend Vendor Quality Events (i.e., Deviations including CAPA management and effectiveness checks, as required).
• Adhere to standard process lead times and ensures alignment with key performance indicators and relevant measures / metrics.
• Possess strong intra- / inter-company communication skills, ability to think critically and influence others, problem solve, and have solid technical writing skills.
• Demonstrate ability to work independently, be organized, multi-task and adjust priorities in a dynamic, fast-paced work environment.
• Collaborate with others while leading projects that drive continuous quality improvements, implement best practices and/or enhance compliance to domestic and international regulatory requirements.

Requirements

• B.S. in Chemistry, Chemical Engineering, or a relevant Life Science degree; advanced degree preferred.
• Requires a minimum of 8 years in the Life Sciences or Pharmaceutical industry with relevant Quality Assurance experience and 5+ years of GMP Vendor Management experience; or an advanced degree with lesser experience or alternate equivalent work experience.
• Expert knowledge of domestic and international GMP regulations.
• Experience in leading projects, problem solving, process improvement with strong negotiation skills.
• Experience and understanding of product formulation and filling, and assembly of drug delivery devices (i.e., combination products), is preferred.
• Experience and understanding of Antisense Oligonucleotide manufacturing processes is desired.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters to achieve corporate, department and personal goals and objectives.
• Continuously looking for opportunities to learn, build skills and share learnings both internally and externally.
• Travel up to 20% may be required.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003822.

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%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $109,911 to $154,495.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.