Ionis Pharmaceuticals
Manager/ Senior Manager - GxP Quality Systems (QA Vendor Management)
Ionis Pharmaceuticals, Carlsbad, California, United States, 92009
Headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been pioneering medical breakthroughs for over three decades. We specialize in RNA-targeted medicines, continually innovating in drug discovery to transform lives for patients with unmet medical needs. Our portfolio includes multiple marketed medicines and a leading pipeline in neurology, cardiology, and other high-need areas. We are committed to advancing RNA therapies and gene editing approaches to provide greater patient value, supported by a strong financial position to achieve our strategic goals.
Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. At Ionis, we foster a challenging, motivating, and rewarding environment that promotes innovation and scientific excellence. We believe our success stems from the exceptional talents and dedication of our employees. We seek diverse individuals with various skills and perspectives to join our team. We invest in creating a work environment—whether onsite, hybrid, or remote—where meaningful relationships are built, and our culture and employees thrive. Building on our rich history, we believe our greatest achievements are ahead. If you are passionate about making a meaningful impact on patients' lives, we invite you to apply, contribute to our culture, and develop your career with us. MANAGER / SENIOR MANAGER – GXP QUALITY SYSTEMS (QA VENDOR MANAGEMENT)SUMMARY: We are seeking an experienced Manager / Senior Manager with expertise in Vendor Management and Internal Audit Programs. The ideal candidate will be highly motivated, detail-oriented, inquisitive, and capable of driving activities to completion within established timelines. This role reports to the Assistant Director, GxP Quality Systems (QA Vendor Management). The primary responsibilities include executing vendor management activities (e.g., onboarding, qualification, auditing, performance monitoring), working with cross-functional teams on change and quality event management, internal audits, material qualification, quality agreements, and risk management. Preference will be given to candidates with strong compliance and Quality System experience, knowledge of domestic and international cGMP regulations (FDA, Eudralex, Health Canada, ICH, MHRA, MHLW), and experience with small molecules, biologics, medical devices, or combination products. Excellent communication, analytical, and problem-solving skills are essential. The role is onsite/hybrid at our headquarters in Carlsbad, CA. RESPONSIBILITIES:
Lead and execute Vendor Management processes ensuring no interruption to business activities. Manage and track vendor requests, risk assessments, and deliver results on time. Plan, conduct, and document cGMP Vendor and Internal Audits per regulatory standards. Manage Vendor Change Notifications, assessing impact and ensuring compliance. Investigate quality events, develop CAPAs, and verify effectiveness. Manage the Quality Agreement Program, negotiating and updating agreements with vendors. Ensure adherence to process lead times and KPIs. Communicate effectively across teams, influence others, and solve problems with technical writing skills. Work independently, organize tasks, and adapt to a fast-paced environment. Lead projects to improve quality and compliance. REQUIREMENTS:
B.S. in Chemistry, Chemical Engineering, or related field; advanced degree preferred. Manager: minimum 3 years in the Life Sciences or Pharma industry with QA experience and 2+ years in GMP Vendor Management; or equivalent experience. Senior Manager: minimum 5 years in the industry with QA and 4+ years in GMP Vendor Management; or 3 years with a master’s degree. Knowledge of domestic and international cGMPs. Experience with quality investigations, problem solving, and process improvements. Travel up to 15% may be required. For more information and to apply, visit http://www.ionis.com, reference requisition #IONIS003729. Ionis offers an excellent benefits package. Details can be found
here . The pay scale ranges from $73,618 to $120,971. No phone calls, please. Principals only. Ionis is an equal opportunity employer, committed to diversity and inclusion, and complies with all applicable employment laws.
#J-18808-Ljbffr
Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. At Ionis, we foster a challenging, motivating, and rewarding environment that promotes innovation and scientific excellence. We believe our success stems from the exceptional talents and dedication of our employees. We seek diverse individuals with various skills and perspectives to join our team. We invest in creating a work environment—whether onsite, hybrid, or remote—where meaningful relationships are built, and our culture and employees thrive. Building on our rich history, we believe our greatest achievements are ahead. If you are passionate about making a meaningful impact on patients' lives, we invite you to apply, contribute to our culture, and develop your career with us. MANAGER / SENIOR MANAGER – GXP QUALITY SYSTEMS (QA VENDOR MANAGEMENT)SUMMARY: We are seeking an experienced Manager / Senior Manager with expertise in Vendor Management and Internal Audit Programs. The ideal candidate will be highly motivated, detail-oriented, inquisitive, and capable of driving activities to completion within established timelines. This role reports to the Assistant Director, GxP Quality Systems (QA Vendor Management). The primary responsibilities include executing vendor management activities (e.g., onboarding, qualification, auditing, performance monitoring), working with cross-functional teams on change and quality event management, internal audits, material qualification, quality agreements, and risk management. Preference will be given to candidates with strong compliance and Quality System experience, knowledge of domestic and international cGMP regulations (FDA, Eudralex, Health Canada, ICH, MHRA, MHLW), and experience with small molecules, biologics, medical devices, or combination products. Excellent communication, analytical, and problem-solving skills are essential. The role is onsite/hybrid at our headquarters in Carlsbad, CA. RESPONSIBILITIES:
Lead and execute Vendor Management processes ensuring no interruption to business activities. Manage and track vendor requests, risk assessments, and deliver results on time. Plan, conduct, and document cGMP Vendor and Internal Audits per regulatory standards. Manage Vendor Change Notifications, assessing impact and ensuring compliance. Investigate quality events, develop CAPAs, and verify effectiveness. Manage the Quality Agreement Program, negotiating and updating agreements with vendors. Ensure adherence to process lead times and KPIs. Communicate effectively across teams, influence others, and solve problems with technical writing skills. Work independently, organize tasks, and adapt to a fast-paced environment. Lead projects to improve quality and compliance. REQUIREMENTS:
B.S. in Chemistry, Chemical Engineering, or related field; advanced degree preferred. Manager: minimum 3 years in the Life Sciences or Pharma industry with QA experience and 2+ years in GMP Vendor Management; or equivalent experience. Senior Manager: minimum 5 years in the industry with QA and 4+ years in GMP Vendor Management; or 3 years with a master’s degree. Knowledge of domestic and international cGMPs. Experience with quality investigations, problem solving, and process improvements. Travel up to 15% may be required. For more information and to apply, visit http://www.ionis.com, reference requisition #IONIS003729. Ionis offers an excellent benefits package. Details can be found
here . The pay scale ranges from $73,618 to $120,971. No phone calls, please. Principals only. Ionis is an equal opportunity employer, committed to diversity and inclusion, and complies with all applicable employment laws.
#J-18808-Ljbffr