Job description
Job Title:
Senior Manager / Assistant Director - QA Vendor Management Specialist
Workspace: Fully remote with some travel
JOB SUMMARY
Our client is one of the
2020 Best Places to Work in San Diego, located, near the North San Diego County city of Carlsbad. The bio-pharma company was founded in 1989 and was purposely designed to create a better, more efficient drug discovery platform, establish a new innovation-centered business model, and maximize the value of every medicine created and get it to the people who need it most as quickly and as efficiently as possible.
With the RNA molecule as the basis of our novel drug discovery platform, they are targeting an unprecedented range of therapeutic areas. Their antisense therapies are disrupting diseases and changing their course – from the rarest of conditions, to those that impact millions of people. They currently have three commercial products and more than 40 potentially transformative medicines in our pipeline designed to treat a broad range of diseases.
The company is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. They believe their success is a direct result of their outstanding employees. They are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Apply with us to experience their unique culture while you develop and expand your career.
Summary:
Seeking an experienced Senior Manager / Assistant Director Quality Assurance with strong knowledge and expertise in GMP Audits (Internal & External) and Vendor qualification and management activities. External suppliers include a variety of Contract Manufacturing Organizations (CMO), Contract testing laboratories, Critical raw materials providers, Equipment service providers, Contract warehousing and distribution 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.
Core competencies/Responsibilities:
- Expertise in applying GMP regulations to API and drug product manufacturing, analytics and other areas
- Assist with execution and management of Internal Audit and Vendor Oversight program
- Planning and conducting audits, authoring audit reports, and follow up on CAPA implementation
- Applying Risk Management principles to qualify and manage external service providers
- Works closely with functional areas to periodically provide applicable vendor performance and quality metrics
- Experience in Discrepancy Management (deviation investigations, CAPA development, Change Control)
- Assist in drafting, negotiating and maintenance of Quality Agreements
- Ability to present and defend the GMP Vendor Management Program in regulatory inspections and management review
- Strong critical thinking, problem solving, influencing, and intra-/ inter-company communication skills
- Ability to work independently, multi-task and adjust priorities in a dynamic environment
Qualification requirements:
- B.S. in Chemistry, Chemical Engineering, or related disciplines; advance degree preferred.
- 3 to 5 years of vendor management experience in bio-pharma space preferred.
- 7+ years in the life sciences industry with Quality Assurance experience and 2+ years with auditing experience
- Experience in Quality Assurance with emphasis on compliance, process improvement, etc.
- Working knowledge of regulations, such as domestic and international GMPs
- Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
- Experience in problem solving, process improvement and negotiations
- Experience in Risk Management and Commercial QA operations is highly desired
- Experience and understanding of drug delivery devices and manufacturing processes is desirable
- Committed to delivering high quality results, overcoming challenges, focusing on what matters
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally
- May require up to 20% travel to CMOs upon lifting of travel restrictions
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