Pfenex Inc.
  • 10-Jul-2017 to 30-Dec-2017 (PST)
  • San Diego, CA, USA
  • Base plus Bonus plus Options
  • Salary
  • Full Time

POSITION SUMMARY

Reporting directly to the Vice President, Global Quality, and in partnership with the Associate Director/Director, Quality Assurance and Quality Control, the Associate Director/Director of Quality Assurance & Contract Service Providers (DCACSP) is responsible for the oversite of Quality Assurance (QA) and Contract Service Providers (CSP) in support of PFEnex's products. The director interfaces and partners with various departments and outside vendors to ensure that QA/CSP related activities are properly managed and executed to support process and method transfer, disposition of products, and to achieve project goals, timelines and deliverables. The DCACSP is also a key member of the quality organization and promotes a Quality culture, and is a subject-matter-expert (SME) for all things associated with quality assurance/CSP's processes, procedures, protocols and general best practices. Finally, the director will lead, develop and mentor team members, as well as external resources, to ensure a cohesive and productive group.

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

Essential Functions

  • Plans, coordinates, leads and executes Contract Service Provider audits and vendor management programs
  • Performs risk assessments as part of supplier certification process, including management of testing of components and devices for cGMP compliance
  • Participates in pre-approval inspection readiness of internal systems and for Contract Manufacturing Organizations (CMOs)
  • Provides support for CSP audits and regulatory inspections serving as a QA escort, as needed
  • Provides pertinent data and reporting to support quality and compliance metrics and trending
  • Develops and maintains CSP scorecard
  • Actively promotes, supports, develops and drives the Company's Quality culture by embedding quality into business processes which support GCP, GLP, GMP's including suppliers, external CMO's, CRO's and contract laboratories
  • Leads, manages, develops, hires and supports team members including indirect reports

Key Responsibilities

  • Actively supports the development of the long-term Quality strategy for the Company's business model and overall quality oversight
  • Acts as Person in the Plant for CMO's, as needed
  • Coordinates with internal customers and execute qualification of drug product and drug substance manufacturers, raw material suppliers, testing laboratories, cell banks, packaging, labeling and distribution centers
  • Develops and presents GMP training sessions for internal employees
  • Develops continuous improvement plan, establish metrics and facilitate review at Quality Operations Review
  • Directs and approves and/or generates GxP documents to include technical transfer, specifications, validations, method validations, risk Assessments, change control, deviations, OOS, batch records and product dispositions
  • Dispositions finished products for pre-clinical, clinical and commercial use
  • Drives continuous improvements and supports the advancement of a broad portfolio of biosimilar products and recombinant vaccines
  • Evaluates supplier responses ensuring appropriate CAPAs are implemented; manages the approved cGMP supplier list, making recommendations to senior management as appropriate
  • Generates COAs as needed for products and oversees revisions
  • Investigates and responds to product complaints
  • Leads and/or supports investigations for change management, product-related deviations, OOS, and CAPAs
  • Manages QA requirements and review/approve nonclinical and GMP batch records
  • Manages regulatory inspections or Board of Health and partner communications to support CMC related activities in Quality response preparations; Proactively lead inspections readiness program and prepare for pre-approval inspections
  • Participates, as appropriate, in the evaluation of the Company's Quality System and processes for optimization and continuous improvement
  • Partners with analytical function to determine product release assays; review release assay data
  • Performs quality review and approvals of validation documentation, and provides general oversight and guidance of validation activities
  • Plans, schedules, conducts and reports internal and external audits (e.g, contract manufacturing organizations; analytical labs; raw material suppliers)
  • Prepares presentations for management review of quality systems & quality management reviews
  • Provides Quality oversight to contract manufacturers; identify GxP quality risks and present integrated risk management solutions to senior leadership and key stakeholders
  • Other duties as assigned or required

JOB SKILLS, ABILITIES AND QUALIFICATIONS

  • BA/BS degree in engineering, life sciences or other relevant biologic, chemistry, biochemistry discipline required
  • ASQ, Black/Green Belt Certifications and/or a MA/MS preferred
  • 12+ years of relevant, progressive and broad-based quality assurance experience required
  • 10+ years of Pharmaceutical/Biopharmaceutical Quality, Compliance, Quality Control experience in support of clinical/commercial manufacturing of Biologics, Sterile Fill finish required
  • 3+ years of managing, leading and developing others required
  • Ability to travel up to 30% (US and International)
  • Demonstrated ability and proven track-record of successfully and efficiently integrating activities and perspectives across functions to achieve key goals and objectives
  • Demonstrated ability to assess and determine the criticality of compliance risks
  • Demonstrated 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
  • Demonstrated ability to directly/indirectly manage teams and individuals in a matrix environment, ability to track team performance against objectives, use of effective meeting management tools and techniques, and knowledge of decision-making and conflict resolution techniques
  • Demonstrated ability to initiate, plan, and execute multiple projects and sub-projects on an ongoing basis
  • Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment
  • Demonstrated ability to think "outside the box" and be strategic in planning short-, mid-, long-term project plans and identifying interdependencies
  • Demonstrated ability to work collaboratively with a variety of individuals within the department, company and external vendors, and customers alike
  • Demonstrated understanding of financial and resource planning systems and processes with the ability to coordinate project-level budget/resource estimates and manage actual vs. plan
  • Excellent working knowledge of national and international pharmaceutical regulations, guidelines and expectations (e.g., FDA GMP, EU GMP, EU Directives, ICH Guidelines)
  • Exceptional communication (verbal, written, presentation), organizational and customer service skills, which enables successful collaboration with key stakeholders; team members; and business partners alike
  • Intermediate-to-advanced level proficiency with LIMS and EDMS systems and softwares
  • Intermediate-to-advanced level proficiency with MS Excel, Project & Visio, including building complex schedules with logical relationships between successors and predecessors (e.g., scheduling; Gantt charts; critical path analysis; tracking project tasks and milestones; resource management; work performance completion; reporting and metrics)
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality Guidelines
  • Manage Regulatory Board Inspections and Audits (e.g., FDA, EMEA, PMDA)
  • Proven track record of data driven decision-making based on industry standards and guidance documentation
  • Strong QA/QC experience in biosimilar and recombinant vaccine biopharmaceutical environment from research and development to commercial
  • Working knowledge of U.S. Government-funded programs is preferred

Additional demonstrated abilities and experience as follows:

  • Ability to digest complex data/information easily and communicates data back in a logical, effective and actionable manner
  • Ability to work flexible work schedules, including weekends, as required
  • Demonstrated ability to obtain and maintain personal credibility quickly; Appreciates and respects the necessity for confidentiality
  • Demonstrated ability to prioritize and multitask in order to meet deadlines and commitments
  • Demonstrated ability to think strategically when planning, managing teams, and managing processes.
  • Demonstrated ability to work in fast-paced, team-oriented and self-directed entrepreneurial environment
  • Demonstrated ability to work independently, set priorities and make decisions with general guidance and supervision
  • Detail oriented and highly organized with a strong business/technical acumen
  • Exceptional listening, observational and problem-solving skills
  • Exceptional time-management abilities and strong follow-through skills required
  • Experience in video and web conferencing tools highly preferred
  • Possesses and demonstrates exceptional technical and practical problem solving capabilities
  • Other skills and abilities as required

Supplemental Experience (Strong Plus)

  • Experience and/or exposure to the full life cycle of a biopharmaceutical parenteral product from development through commercial launch
  • Experience working in a start-up or fast-growing company strongly preferred
  • General understanding of GLP, cGMP, GxP, environments
  • Knowledge and experience level with BLA/NDA/CMC regulatory & industry guideline requirements required

Additional Information:

*All new hires are required to go through a background and reference check
*Affirmative Action and Equal Opportunity Employer (EOE)
*No agencies or phone calls please
*Pfenex celebrates the diversity of life and welcomes all individuals to apply
*Pfenex does not currently offer sponsorship or consideration to those on an H1-B or other similar visas at this time

Please note that limited relocation IS offered for this position

Pfenex Inc.
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