Senior Associate or Manager - Quality Assurance / Compliance (QA/C)

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!

SENIOR ASSOCIATE OR MANAGER QUALITY ASSURANCE / COMPLIANCE (QA / C)

We are seeking an experienced Quality Assurance professional to join our Quality Assurance / Compliance (QA / C) group at the Sr.

Associate or Manager level. This individual’s primary responsibility will be to manage and assure the compliance and quality of Ionis’ in-house and contracted packaging and labeling operations with respect to applicable domestic and international regulatory requirements and industry guidelines (as related to cGMP).

The role will function as an individual contributor and must be able to ensure progress and completion of responsibilities in accordance with established departmental goals and objectives or project plans.

The individual must be able to fulfill the requirements of Ionis’ Quality System procedures (e.g., batch record review, change control, corrective and preventive actions, deviations and investigations, external / internal audits, lot disposition / release, Out-of-Specification / Out-of-Trend results, risk management, etc.

while utilizing 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.

PRIMARY RESPONSIBILITIES :

• Ensure the compliance of manufacturing and testing activities with respect to applicable domestic and international and other regulatory cGMP expectations and requirements, and industry guidelines and to Ionis’ QMS and SOPs.
• Support all clinical trial material / IMPs packaging and labeling activities / operations, and distribution (e.g., packaging summaries and specifications, labels and labeling, master batch records, executed batch record review and approval, deviations, review BME analytical testing, and when needed on-site clinical packaging activities).
• Prepare customs and importation documentation required for international clinical trial material / IMPs and sample shipments.
• Prepare communications to support Clinical Supplies department (e.g., expiry date memos and site destruction authorization).
• Review and provide input (e.g., failure analysis, problem solving, and risk assessment and mitigation) to resolve moderately complex quality events and issues related to the manufacture or testing of clinical trial material / IMPs.
• Develop, implement, and deploy enhancements to Ionis’ Quality System policies and procedures, and support continuous improvement programs.
• Perform internal audits of in-house cGMP operations and external audits of Ionis’ vendors, Contract Manufacturing Organizations and Testing Laboratories, as assigned.
• Support domestic and international regulatory authority inspections and partner cGMP audits of Ionis Pharmaceuticals, as needed.

REQUIREMENTS :

• A bachelor’s degree in a science discipline is required with a broad knowledge of drug development and at least six (6) years of industry experience, is preferred.
• Prefer a candidate with at least four (4) years Quality Assurance related experience in a cGMP environment is essential with a proved track record in clinical trial material / IMP batch records review and quality control data, performing lot disposition activities, including handling / managing / resolving quality events and issues.
• A strong understanding of quality guidelines and regulatory requirements as they apply to the industry is required.
• Experience using electronic quality management systems (e.g., Microsoft Dynamic365, Veeva Quality System, etc.).
• Experience performing internal and external audits against domestic and international regulatory requirements and industry expectations as related to cGMP activities is desired.
• Must be organized, adaptive, and detail oriented, with the ability to multitask, and manage multiple priorities with aggressive timelines.
• Ability to interact with internal and external customers (e.g., partners and vendors).
• Customer oriented with excellent communication skills and the ability to apply pragmatic logic to problem solving and issue resolution.
• Experience with respect to drug product formulation, sterile filling, and finishing is a plus.

COMPETENCIES IDENTIFIED FOR SUCCESS :

• Excellent interpersonal, communication (written and verbal) and collaboration skills.
• Demonstrates attention to detail and high quality while meeting deadlines and commitments.
• Patient and results focused.
• Exhibits integrity in words and actions.
• Ability to adjust to and manage change.
• Show resilience, be flexible and adaptable.
• Outstanding organizational and time-management skills with ability to multitask and prioritize.

Benefits

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