Manager, Quality Assurance (QA)

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.

MANAGER – QUALITY ASSURANCE (QA)

Seeking an experienced Quality Assurance professional to join our Quality Assurance / Compliance (QA/C) group at the Manager level. This individual’s primary responsibility will be to assure the compliance and quality for contracted manufacturing and testing activities for Drug Products (DP) and Device Assemblies with respect to applicable domestic and international regulatory expectations and requirements, and industry guidelines (as related to cGMP), and Ionis’ Quality Management System and Standard Operating Procedures (SOPs). The successful candidate will function as an individual contributor and must be able to: (1) ensure progress and completion of responsibilities in accordance with established departmental goals and objectives or project plans and milestones; (2) fulfill the requirements of Ionis’ Quality Management System and Standard Operating Procedures (e.g., auditing, batch record review, change control, corrective and preventive actions, design control, deviations and investigations, lot disposition and release, Out-of-Specification / Out-of-Trend results, risk management, etc.); (3) utilize sound compliance and scientific judgment with consideration to risks and mitigation strategies to develop solutions to a variety of moderately complex quality events and issues; and (4) manage / provide quality oversight for contracted manufacturing and testing activities and for providing decision-making regarding any issues or quality events, as appropriate.

PRIMARY RESPONSIBILITIES:

• Assure the compliance and quality for contracted manufacturing and testing activities for Drug Products (DP) and Device Assemblies (e.g., Autoinjectors and Filled Syringe Safety Devices) with respect to applicable domestic (FDA – 21 CFR Parts 4, 210 / 211 and 820) and international (e.g., EMA, Health Canada, MHLW, ICH, and ISO – 13485 and 14971) regulatory expectations and requirements, and industry guidelines (as related to cGMP), and Ionis’ Quality Management System and Standard Operating Procedures (SOPs)
• Perform batch record review and lot disposition activities for Drug Products (DP) and Device Assemblies (e.g., Autoinjectors and Filled Syringe Safety Devices)
• Review and approve documentation in partnership with external / internal business partners
• Review analytical data packages associated with Drug Products (DP) and Device Assemblies with respect to release and stability testing; must be able to recognize and communicate trends associated with the data over time
• Provide quality oversight for contracted manufacturing and testing activities for Drug Products (DP) and Device Assemblies and for providing decision-making during manufacturing activities, i.e., unit operations, as needed
• Review and provide input [e.g., troubleshooting, failure analysis, problem solving, and risk management (assessment and mitigation)] for quality events or issues related to manufacturing and testing activities for Drug Products (DP) and Device Assemblies
• Develop solutions and resolve a variety of moderately complex quality events and issues (e.g., Deviations, Investigations, Out-of-Specification / Out-of-Trend investigations or any other quality event and issue as relates to Drug Products (DP) and Device Assemblies)
• Review and approve technical reports supporting contracted manufacturing and testing activities for Drug Products (DP) and Device Assemblies, as well as analytical method validation protocols / reports
• Perform internal audits of in-house cGMP operations and external audits of Ionis’ vendors, Contract Manufacturing Organizations and Testing Laboratories (i.e., CMOs and CTLs), as assigned
• Supports the conduct of domestic and international regulatory authority, as well as partner cGMP audits of Ionis Pharmaceuticals, as appropriate
• Develop, implement and deploy enhancements to Ionis’ Quality System policies and procedures
• Other duties, as assigned

REQUIREMENTS:

• Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, etc.) with a broad knowledge of drug development and at least seven (7) years of industry experience
• At least five (5) years Quality Assurance related experience in a cGMP environment
• Knowledge of FDA, EMA, Health Canada, MHLW, and ICH regulatory requirements and other guidelines related to cGMP activities
• Knowledge of Design Control and Device regulatory requirements and combination product development and commercialization is a plus
• Experience performing batch record and quality control data review (with a strong attention-to-detail), and managing GMP documents and records
• Experience performing lot disposition activities and handling / managing / resolving quality events and issues
• Experience reviewing technical and validation protocols, records and reports
• Experience using electronic quality management systems (Veeva QualityDocs and QMS is a plus)
• Experience performing internal and external audits against domestic and international regulatory requirements and industry expectations as related to cGMP activities
• Possess effective communication (verbal and written) skills
• Possess solid interpersonal and teamwork skills, and a strong work ethic
• Ability to interact with internal and external customers (e.g., partners and suppliers / vendors)
• Ability to manage multiple priorities with aggressive timelines at a high level of productivity in an intense work environment

Excellent salary and benefits package offered.

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003037

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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