Quality Assurance Manager

Location
Carlsbad, CA
Posted
Feb 20, 2019
Ref
19-0033
Required Education
Bachelors Degree
Position Type
Full time

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.

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 individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.

QA MANAGER – QUALITY ASSURANCE / COMPLIANCE (QA/C)

SUMMARY:

This individual’s primary responsibility will be to assure the compliance and quality of Ionis’ Drug Product (DP) manufacturing and testing activities with respect to Ionis’ procedures and applicable domestic and international regulatory expectations and requirements.  The incumbent 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, (2) fulfill the requirements of Ionis’ Quality System procedures (e.g., auditing, change control, corrective and preventive actions, deviations and investigations, risk analysis and mitigation strategies, etc.), and (3) utilize sound compliance and scientific judgment to develop solutions to a variety of moderately complex quality events and issues.

RESPONSIBILITIES:

  • Ensure compliance of Ionis’ Drug Product manufacturing and testing activities to internal procedures as well as FDA, EMA, Health Canada, MHLW, and ICH, and other regulatory requirements and industry expectations
  • Review batch records, quality control data and testing records, and perform lot disposition activities for Drug Product (DP)
  • Review Drug Product stability data and testing records, as necessary
  • Review and provide input (e.g. failure analysis, problem solving, and risk assessment and mitigation) for quality activities and events related to the manufacture or testing of Drug Product (DP)
  • Provide quality oversight and support (i.e. decision-making) to contract manufacturing organizations with respect to Drug Product (DP) formulation, sterile filling, visual inspection, and secondary assembly and packaging activities
  • Resolve moderately complex quality events and issues (e.g. deviations, investigations, Out-of-Specification / Out-of-Trend investigations, or any others as assigned)
  • Perform internal audits of Ionis’ cGMP operations and perform external audits of Ionis’ suppliers and contract manufacturing organizations and testing laboratories, as assigned
  • Develop and implement enhancements to Ionis’ Quality System procedures
  • Support external regulatory or partner cGMP audits, as assigned
  • Other duties as assigned

REQUIREMENTS:

  • Bachelor’s Degree (Master’s a plus) in a relevant discipline (e.g., chemistry, biological sciences, etc.) with a broad knowledge of Drug Product 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 Annex 1, Annex 16, FDA, EMA, Health Canada, MHLW, and ICH regulatory requirements and other guidelines related to cGMP operations
  • Experience performing audits against domestic and international regulatory requirements and industry expectations as related to cGMP operations
  • Experience performing batch record batch record and quality control data review is essential
  • Experience performing lot disposition activities, managing quality events and issues, and performing systems related internal and external audits is essential
  • Experience with respect to Drug Product formulation, sterile filling, visual inspection, and secondary assembly and packaging is essential
  • Experience using electronic quality management systems (Veeva QualityDocs and QMS is a plus)
  • Possess effective communication (verbal and written) and strong interpersonal and teamwork skills
  • 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 # 19-0033

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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