Senior Manager, GxP Quality Systems (QA 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’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 work environment 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!

MANAGER / SENIOR MANAGER – GXP QUALITY SYSTEMS (QA VENDOR MANAGEMENT)

SUMMARY :

We are seeking an experienced Manager / Sr. Manager with strong knowledge and expertise in Vendor Management and Internal Audits Programs. The ideal candidate will be highly motivated, detail-oriented, inquisitive, and can drive activities, assignments, and tasks to completion in accordance with established expectations and timelines. This role is for an individual contributor reporting to the Assistant Director, GxP Quality Systems (QA Vendor Management).

Primary responsibilities will focus on operational execution of vendor management activities (e.g., vendor on- and off-boarding, service provider / vendor qualification, auditing, performance monitoring, and measurement / metrics), working with multi-disciplinary and cross-functional teams regarding change and quality event management (including CAPA), internal audits, material qualification, quality agreement preparation and management, and risk management.

Preference will be given to candidates possessing strong compliance and Quality System experience (including QA applications), and knowledge of domestic and international cGMP regulatory requirements (e.g., FDA, Eudralex, Health Canada, ICH, MHRA, MHLW, etc.). Experience with small molecules, biologics, medical devices and / or combination products is desired. Candidates must also have excellent verbal and written communication skills, and strong analytical and problem-solving abilities to address issues of moderate complexity. 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. Flexible work arrangements can be accommodated.

RESPONSIBILITIES :

• Lead and execute Vendor Management Program processes in accordance with the established risk-based model ensuring there is no interruption to business activities.
• Manage and track new Vendor Requests including working with our customers / stakeholders regarding risk assessment and scoring and delivering results in accordance with agreed upon business timelines.
• Strong knowledge and experience with planning, preparing, conducting, and documenting cGMP Vendor and Internal Audits (including onsite, remote and questionnaire audits) in accordance with applicable domestic or international regulatory requirements and industry best practices.
• 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.
• Perform quality event investigations including CAPA development and Effectiveness Checks, as required.
• Lead and manage Quality Agreement Program. Initiate, negotiate, establish, and periodically update new and existing agreements with our cGMP vendors, as applicable.
• Adheres to standard process lead times and ensures alignment with key performance indicators and relevant measures / metrics.
• Strong intra- / inter-company communication skills, ability to think critically and influence others, and problem solve, and possesses solid technical writing skills.
• Ability to work independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment.
• Collaborate or lead projects that drive continuous quality improvements, implement best practices and / or enhance compliance to domestic and international regulatory requirements.

REQUIREMENTS :

Benefits

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