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Quality Operations Manager, Drug Substance/ Drug Product

Location: San Diego, CA, United States
Job # 11143418
Date Posted: 07-12-2018
Quality Operations Manager, Drug Substance/ Drug Product
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert or Extend)
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 Operations Manager to be responsible for providing Quality Assurance (QA) support to manufacturing, Quality Control, analytical development at our Contract Manufacturing facilities. You will have the opportunity to work closely with our contract manufacturing contacts in manufacturing, Quality and Quality Control areas as well as with other associates in support of Clinical product manufacturing and overall commercialization activities. This candidate will provide oversight and verify that activities are appropriately following cGMP's. This individual will spend time at both our contract manufacturing sites and at our corporate office.

  • Review and approve GMP documentation (protocols, SOP's , technical reports, methods, etc)
  • Disposition all finished products for clinical and commercial use
  • Lead and/or support investigations for change management, product-related deviations, OOS, and CAPAs
  • Manage QA/QC requirements and review/approve GMP batch records
  • Review/Approve Validation protocols and reports to ensure compliance
  • Review /approve master batch records, batch records, associate testing
  • Perform drug substance/drug product disposition and generate Certificate of Analysis
  • Plan, schedule, conduct and report internal and external audits (ie, contract manufacturing organizations, analytical labs, raw material suppliers, etc)
  • Perform quality review and approval of validation documentation and provide general oversight of validation activities
  • Evaluate and track on site/on the floor observations.
  • Review relevant section of regulatory filling
  • Collaborate to drive closure of investigations/deviations and continuous improvement activities
  • Perform risk assessments, as part of supplier certification process, including management of testing of components and devices for cGMP compliance
  • Participate in pre-approval inspection readiness of internal systems and for CMOs
  • Issue, review, and/or approve all clinical labeling issued to Manufacturing
  • Support other cGMP QA efforts, maintain close contact with the QC group, and review/approve product specifications
  • Provide support for partner audits and regulatory inspections serving as a QA escort, as needed
  • Prepare presentations for management review of quality systems
  • Provide pertinent data to support quality and compliance metrics and trending
  • Participate, as appropriate, in the evaluation of our Quality System and processes for optimization and continuous improvement
  • A minimum of 8 years working in a biotech or pharmaceutical quality assurance environment, managing GxP functions involving phases 1-3 of clinical studies, with extensive cGMP auditing experience  
  • Ability to coordinate and lead diverse audit teams in evaluation of cGMP facilities and quality systems, including raw material suppliers, testing laboratories, and packaging, labeling, and distribution centers  
  • Experience with manufacturing controls of sterile parenteral processing and solid dosage forms, including devices
  • Excellent working knowledge of national and international pharmaceutical regulations, guidelines and expectations (FDA GMP, EU GMP, EU Directives, ICH Guidelines, etc.)
  • Must be able to read and interpret complex documentation for compliance with procedures, standards and regulations
  • Ability to assess and determine the criticality of compliance risks
  • Proven track record of data driven decision-making based on industry standards and guidance documentation
  • Clear and succinct writing style; excellent communication skills, both verbal and written
  • Strong observational and listening skills
  • Ability to work collaboratively with people at all levels: operators through the CEO
  • International and domestic travel preparedness
  • Attention to detail and proper use of tools of information processing
  • Diplomatic approach to help mitigate and resolve conflict
  • Ability to travel up to 40% (Domestic, international rare).
  • Significant experience and understanding of CGMP, GLP, and ICH regulations required.
  • Analyzes reports, metrics and results as required; provides SME and strategic guidance based on findings.
  • Appreciates and respects the necessity for confidentiality.
  • Demonstrated ability to build relationships and work collaboratively with a variety of individuals within the department, company and external vendors alike.
  • Demonstrated ability to lead, manage and motivate others to support objectives and mission and to achieve goals set out (even if not direct reports).
  • Demonstrated ability to work in fast-paced, team-oriented and self-directed environment.
  • Demonstrated strategic planning with proven ability to communicate a vision and drive results.
  • Demonstrated, proven and effective project- and time-management abilities and follow-through skills.
  • Detail oriented and highly organized with a strong business/technical acumen.
  • Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Significant experience using computers and software programs required (e.g., LIMS, MS Office Suite; EDMS software)
  • Other skills and abilities as required
Supplemental Experience as a Strong Plus
  • Experience working in a biosimilars drug-development organization highly preferred.
  • Experience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 4) highly preferred.
  • Bachelor's degree in science, biochemistry, microbiology, engineering or equivalent discipline. Master's degree preferred
Please submit your resume in PDF or Word format to be in consideration. #DI
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