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
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