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Quality Assurance Manager - Person in Plant

Location: San Diego, CA, United States
Job # 11568311
Date Posted: 11-05-2018
Quality Assurance Manager - Person in Plant
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert)
Pay: Depends on Experience
Start Date: ASAP
  
Client Overview
Our client is a clinical late-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. We have the highest-quality protein production and bioanalytic technology platform approach that allows us to create biosimilars in a highly efficient manner from concept to commercialization.

Job Description
We are looking for a Quality Assurance Manager / Person in Plant to be a key member of our Quality Organization. In this role, you will be responsible for Quality Assurance in support of one of our main products. Strong QA experience in biosimilar biopharmaceutical and medical device/combination product environment from research and development to commercial.

In this role, you will interface closely with various departments to ensure that QA related activities both onsite and at current service providers are properly managed to support process/method transfer, disposition of products, achieve project goals, and timelines.  We are interested in candidates with a proven track-record of successfully and efficiently integrating activities and perspectives across functions to achieve our goal of delivering Quality cost-effective therapies that enable access to patients who need them. 

Responsibilities:
  • Provide Quality oversight to contract service provider, identify GxP quality risks and present integrated risk management solutions to Project team and Quality leadership team.
  • Provide Person in the Plant presence through development and supply of GMP materials that meet ours and industry compliance standards
  • Evaluate and track on site/ on the floor observations
  • Issue, review and /or approve labeling issued to Manufacturing
  • Review and approve GMP documentation (protocols, technical reports, specifications, test methods, URS, SOPs. IQ, OQ, PQ qualification documents, FAT, SAT, SOPs, tech transfer, risk assessments)
  • Review /approve master batch records, executed batch records, test data package and associated documents
  • Perform product disposition and review/approve CoA.
  • Review /approve validation protocols/reports, related documents and provide general oversight of validation activities
  • Collaborate and support investigations, change management, product related deviations, OOS and CAPAs and help drive to closure
  • Plan, schedule, conduct and provide report for internal and external audits at contract service providers including contract labs and vendors
  • Perform risk assessment as part of supplier qualification process, including management of testing of components and devices for cGMP compliance
  • A monthly qualitative accurate (metric) update demonstrating progress and/or challenges in key project areas. Support with quantitative data
  • Partner with Manufacturing, QC, workstream team to ensure project timelines are achieved
  • Facilitate meetings with CSP and with workstream team and other teams, members as required by project needs
  • Collaborate and partner with Process Development, Analytical and Manufacturing Team, Program Management, Quality Control, Supply Chain, Regulatory and CMC in support of our product's operational and registration activities.
  • Support regulatory inspection, due diligence audits, serving as QA escort, as needed
  • Review relevant sections of the regulatory filing and support Quality response preparations
  • Participate in pre-approval inspection readiness of internal systems and for contract service providers
  • Prepare trending/metrics for Quality management review
Experience:
  • A minimum of a Bachelor of Science degree in life sciences or other relevant biologic, chemistry, biochemistry, engineering discipline required; Master's degree preferred.
  • 10+ years of Pharmaceutical/Biopharmaceutical Quality, Compliance medical device, combination product experience in support of clinical/commercial manufacturing of Biologics, Sterile Fill finish required
  • 5+ years quality engineering experience which must be in the medical device/combination product industry with FDA experience
  • 5+ years of managing and leading others required
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required.
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11, 21CFR820 and ICH Quality Guidelines, Quality System Regulations/Good Manufacturing Practices, ISO 13485, ISO 9001, ISO 14971
  • ASQ, Black Belt/Green Belt certifications a plus.
  • Ability to travel up to 40% (US and Internationally)
  • Ability to work flexible work schedules.
  • Excellent computer, verbal, and written communication skills
  • Passion for manufacturing with an on-floor presence to advance product quality standards
  • Ability to work in a team environment
  • Innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Proven ability to work in a lean organization and creatively tackle problems.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.
  • Experience in medical device and combination product organization
  • Experience with biopharmaceutical product PD, research, clinical, and commercial manufacturing
  • Significant experience with MS Office Suite; Project, Visio, LIMS, and EDMS.
Please submit your resume in PDF or Word format to be in consideration. #DI
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