Sr. Director Quality Control

Company: KBI Biopharma Inc.
Location: Durham
Posted on: September 21, 2023

Job Description:

Sr. Director Quality Control page is loaded Sr. Director Quality Control Apply locations USA - NC - Durham - National Way time type Full time posted on Posted 30+ Days Ago job requisition id R00005233 JOB SUMMARY:This position is responsible for day-to-day management of the Quality Control team which includes both QC Analytical and QC Microbiology. This incumbent will be responsible for hiring, managing performance, and development of reporting staff. The individual must have proven knowledge of Quality Control system development including creation of SOPs, Technical Documents, Test methods, etc. The individual in this role is recognized as a subject matter expert with regard to QC Analytical and QC Microbiology practices and procedures. The incumbent will serve as the main point of contact for QC Analytical and QC Microbiology activities. In this role the individual must be able to identify and communicate improvement opportunities and results. The incumbent must be able to identify and address short term, intermediate, and long-term issues, and be able to appropriately resolve conflict and prioritize work as necessary.

• Responsible for planning, scheduling and organizing QC activities related to meeting the compliance, supply, profit plan and strategy objectives of KBI.
• Responsible for initiation and overseeing projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement.
• Responsible for leadership of method validation of transferred methods.
• Responsible for collaborating with cross-functional teams as the Quality Control Subject Matter Expert.
• Responsible for supporting internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties.
• Responsible for supporting internal and external cGMP manufacture and supply of client project materials including oversight of cGMP sample handling, testing, QC release, method data trending, and out of specification investigations.
• Responsible for oversight of contract QC laboratories including routine performance management and participating in audits to ensure sustained quality analytical deliverables.
• Responsible for maintaining current knowledge base of regulations, corporate policies and industry best practices, trends and standards to ensure the QC function remain in compliance with applicable company requirements and quality regulations.
• Responsible for creation/enhancing QC Analytical and QC Microbiology quality systems and implementation of those systems.
• Responsible for all other duties as assigned by the VP of Quality.MINIMUM REQUIREMENTS:
  • PhD and 5+ years directly related experience; or M.S. and 10+ years of related experience; or B.S. and 15+ years' experience; prior experience must include management experience.
  • Excellent written and verbal communication skills are required. Must be organized and able to focus in a fast-paced, multi-tasked environment, and maintain operational efficiency and positive demeanor. Must be able to react to change proactively and handle other essential tasks as assigned. Must demonstrate leadership and the ability to collaborate and work with cross functional teams.
  • Must have knowledge of cGMPs and biotechnology-derived product relations. Previous contract manufacturing facility experience is preferred.SALARY RANGE: $195,000 - 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. Similar Jobs (1) Director, Quality Assurance - Facilities and Compliance locations USA - NC - Durham - National Way time type Full time posted on Posted 20 Days Ago About Us At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.
    We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one's technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.
    If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.Please Note: To 3rd Party Search Firms/Employment Agencies: -All inquiries must be directed to staffinginquiry@kbibiopharma.com . Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position .KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.
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Keywords: KBI Biopharma Inc., Durham , Sr. Director Quality Control, Executive , Durham, North Carolina