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Senior Director, Site Head Of Quality

Company

KBI Biopharma
Address , The Woodlands, Tx
Employment type FULL_TIME
Salary $203,000 - $230,000 a year
Expires 2023-07-21
Posted at 11 months ago
Job Description
Job Summary
The cell therapy unit of KBI Biopharma is a contract development and manufacturing organization located in The Woodlands, TX. The Senior Director, Quality Site Head will lead the Quality Assurance and Quality Control departments for the site.
Quality Assurance
  • The Senior Director, Quality Site Head is responsible for raw material inspection and release, Quality on the floor, disposition of drug product/drug substance, QA review of quality control data, root cause analysis, risk management, technical writing, deviation, change and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement.
  • Partner with Global Quality in ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site.
Quality Control
  • The Senior Director, Quality Site Head is responsible for QC Analytical and QC Microbiology. He/she is responsible for oversight of QC Analytical tasks including but not limited to flow cytometry, qPCR, Elisa, and Cell based assays. He/she is responsible for oversight of QC Microbiology tasks including BacT, Myco Seq, Endosafe, EM Trending, Sample Accessioning, and Raw Material Program Management.
  • Strong knowledge of sterile processing in a sterile manufacturing facility is required. Proven skills in the knowledge of 21CFR210, 21 and 1271 is also required.
  • In consultation with the SVP of Quality and Regulatory, the Senior Director, Quality Site Head holds final accountability for and decision making on the matters relating to GMP compliance for the site.
  • This role is key in collaborating with site operations (Manufacturing, Facilities & Engineering, Supply Chain, and Operational Excellence) to ensure appropriate quality oversight. Partnership with the Senior VP, Operations & Site Head is crucial to ensure the site’s success.
Job Responsibilities
  • Responsible for developing and monitoring appropriate metrics to track quality and process improvements.
  • Responsible for developing the Quality staff to enhance capability and to ensure continuity of the Quality function.
  • Key contributor to long term strategic planning and part of senior leadership team.
  • Work with internal and client teams to establish Quality strategy, define roles and problem solve.
  • Responsible for ensuring site compliance with GMP and regulatory requirements.
  • Responsible for providing oversight of Data Integrity programs supporting both clinical and commercial operations from a global perspective.
  • Responsible for problem solving, risk assessments and implementation of corrective actions resulting from compliance issues at The Woodlands TX facility.
  • Responsible for ensuring proper alignment of the quality function to manufacturing, engineering/maintenance, validation, supply chain and any other areas as required.
  • Responsible for establishing strong relationships with internal and external customers to build quality aspects and objectives into new and current business initiatives.
  • Responsible for supporting all client projects as the quality lead and attending all meeting for current and prospective clients.
  • Responsible for collaborating with all departments to ensure quality standards and GxP compliance are met and maintained.
  • Responsible for development of required site processes and competencies to ensure quality standards are implemented in accordance with corporate goals and objectives.
  • Lead, assess, mentor and develop departmental personnel. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
  • Oversight and implementation of quality systems, standards and procedures for inspecting, testing and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Leaders on continuous improvement initiatives.
  • Responsible for management, leadership and oversight of the Quality Assurance and Quality Control departments.
  • Responsible for any other duties assigned by Site Head, global QLT or Senior VP of Quality and Regulatory.
  • Responsible for providing leadership and strategic direction to the site.
Minimum Requirements
  • Sterile Gowning
  • Risk Management
  • Manufacturing
  • QC Analytical
  • Sterile Manufacturing experience at a GMP Sterile Manufacturing Facility
  • Data Integrity
  • Support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies.
  • Flow Cytometry
  • Cell based assay (CBA)
  • Sample Accessioning
  • QC Microbiology
  • Must partner/collaborate with the Ops Site Head to ensure success of the business
  • Experience developing, implementing, and executing strategic plans and objectives for organizations and departments.
  • Demonstrated level of respect for individuals
  • Must have thorough knowledge of cGMPs and biotechnology-derived product regulations. Also requires a demonstrated track record in the following key areas:
  • Supply Chain
  • EM Trending
  • Strong orientation for Quality and Customer Service
  • Root Cause Analysis
  • QPCR
  • Continuous Improvement
  • Myco Seq
  • Validation Management
  • Training
  • Technical Writing
  • Endosafe
  • Elisa
  • 21CFR 210, 211 and 1271 knowledge
  • Record of innovation
  • Strong collaboration and team building skills
  • Vendor/Material oversight
  • BacT
  • Raw Material Program Management
  • Sterile Processing (ISO5/ISO7/ISO8)
  • QMS Oversight
  • Regulatory Inspection management
  • Quality Assurance
  • High level of integrity and personal responsibility
  • Client/Regulatory Inspection
  • Lovo, Xuri, Prodigy, rapid point experience
  • Ways of working
  • Minimum requirement is a Bachelor of Science degree in a scientific discipline with 7 years of quality management experience plus at least 3 years’ experience serving in a relevant technical management capacity required. A Master’s degree with 6 years or a Doctorate degree with 4 years of quality experience would be considered. At least 10 years of regulated pharmaceutical industry experience. CMO experience preferred.
Salary Range: 203,000 - $230,000
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.