Director, Quality Assurance - GMP Vendor Management

Location
92010, Carlsbad
Posted
Jul 15, 2021
Required Education
Bachelors Degree
Position Type
Full time

Ionis Pharmaceuticals, Inc., one of the 2020 Best Places to Work in San Diego, is in the North San Diego County city of Carlsbad.  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 – Spinraza, the standard of care for all forms of spinal muscular atrophy; Tegsedi, the first approved RNA-targeted therapy for polyneuropathy caused by hereditary ATTR (transthyretin) amyloidosis; and Waylivra, the only approved treatment for familial chylomicronemia syndrome (FCS). Ionis has a premier late-stage pipeline highlighted by our industry-leading neurological and cardiometabolic franchises. Scientific innovation began and continues at Ionis with the understanding that sick people depend on the success of the company.  This belief drives Ionis’ vision of becoming one of the most successful biotechnology companies. 

 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. Ionis’ medicines span multiple therapeutic areas, routes of administration and diverse patient populations, and Ionis innovation is driving meaningful progress for many of the most challenging health issues.

Ionis is building upon our innovative research and drug development excellence to provide greater value to patients.  Based on the breadth and remarkable progress of our pipeline, Ionis is projecting to have a vast number of new transformational products on the market in the coming years. Ionis is 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 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.

DIRECTOR, QUALITY ASSURANCE - GMP VENDOR MANAGEMENT

This position will lead the GMP Vendor Management Program at Ionis Pharmaceuticals, including leading vendor audits, qualification, and requalification schedule.  This high impact position reports to the Head of GMP Quality.

This person is responsible for the oversight of all Quality aspects performed at manufacturing and testing partners of Ionis’s clinical and commercial products in the following modalities and unit operations: Pharmaceuticals, Oligonucleotides, Devices, Combination Products, RSMs, Drug Substance, API, Drug Product, Aseptic Fill Finish Operations, Device Assembly and Packaging. This person may also lead and/or support continuous improvement initiatives related to Ionis’s QMS and procedures for CMO and partner oversight.

The position requires an experienced QA professional with strong expertise in GMP Audits and Vendor Qualification. Auditees include a variety of GMP service providers including Contract Manufacturing Organizations (CMO), Contract testing laboratories, Critical raw materials providers, shipping and warehousing vendors, and software vendors among others. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required. Since Ionis finished products come under combination drug products regulations, expertise with device vendors as well as design control oversight is desirable.

The incumbent would develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.

 Core competencies:

  • Expertise in applying GMP regulations to API and drug product manufacturing and analytics including areas listed below:
  • Pharmaceutical manufacturing and Quality Assurance
  • Discrepancy Management (deviation investigations, CAPA development, Change Control)
  • Planning and conducting audits, authoring audit reports, and follow up on CAPA implementation
  • Risk Assessment to guide level of QA audits and oversight
  • Strong critical thinking, problem solving, influencing, and intra-/ inter-company communication skills
  • Multi-task and adjust priorities in a dynamic environment

Responsibilities:

  • Enhance/Upgrade Vendor Management Program by authoring/revising QA procedures
  • Develop internal and external audit schedules and execute per audit plan
  • Applying Risk Management principles to qualification and oversight of external service providers
  • Assist in drafting, negotiating and maintenance of Quality Agreements with CMO’s
  • Present and defend the GMP Vendor Management Program in regulatory inspections and management review
  • Works closely with functional areas to periodically provide applicable vendor performance and quality metrics
  • Maintain current knowledge of Regulatory concerns on vendor management
  • Implement design control requirements as per internal procedures
  • Coordinate design review meetings with key stakeholders
  • Coordinate Review and assembly of Design History Files

Requirements:

  • B.S. in Chemistry, Chemical Engineering, or related disciplines; advance degree preferred.
  • Fifteen + years of experience in GMP manufacturing with minimum of ten years in a QA auditing role
  • Strong knowledge of FDA, EMA, ICH regulations and guidelines on vendor management program
  • FDA QSR 21 CFR Parts 4 and 820 / ISO 13485, ISO 14971, and Regulation (EU) 2017/745).
  • Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
  • Experience in presenting and defending Vendor Management program during regulatory inspections
  • Experience in problem solving, process improvement, negotiations, and supervision
  • Experience in Risk Management and Commercial QA operations is highly desired
  • Experience and understanding of drug delivery devices and manufacturing processes is desirable
  • Design Control compliance experience working with clinical and medical groups is desirable
  • May require up to 20% travel to CMOs upon lifting of travel restrictions

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 #DIREC02608

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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