Job Details
Job Description
Job Description
Our client a growing company with multiple plants in the US, needs a
Director of Quality
at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to
$190K
+
Annual Bonus
+
Relocation assistance +
Full Benefit Package.Job Posting # 2636R
Job Title :
Director of Quality - PharmaceuticalLocation:
Lawrence, KS
Compensation:
Annual Salary of
$150K - $190K
+ Annual Bonus
Target 20%
Relocation:
YES
- Client offers relocation assistance and payments for expenses
Benefits:
Full package for medical, dental insurance,
401K,
etc.
This is a privately held company in business for
40 years
with
300 people
at manufacturing sites in
CA, KS
Group Info:
Be part of the medical device and pharmaceutical contract manufacturing site with around
100+ employees
and expected to grow to
150 people
soon due to major expansion in
Pharma manufacturing .
The
new operation expansion
is for Pharma -
Blow
Fill Cap BFC
of
Sterile Solutions.
This Quality group has around
25 people
from Quality Control, Quality Assurance, Validation, Compliance. This role will report to the
Sr. Director of Quality . The
3
Managers from QA, QC
and Quality
with total of
20 people
will report to this person.
Job Summary:The
Quality Director
develops and deploys the quality system for a small to mid-size plant manufacturing
Medical Devices and Pharma Solutions , while assuring systems and procedures for regulatory compliance are established and deployed.Will periodically review the suitability and effectiveness of the quality system with executive management as well as manage regulatory inspections.Job Description:Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and company policiesDevelops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirementsDrives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvementsInteracts frequently with all levels of internal management as well as across functions and franchisesManages interactions with customers and regulators concerning the quality of products, systems, and processesResponsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibilityCandidate Must Have :Bachelors of Science in Chemistry, Microbiology, Engineering
or related degreeMin. 10 years
of experience in
Medical Device or Pharma
IndustryMin. 5 years
of
Quality Management
experience in the
Pharmaceutical
IndustryExcellent people, communication and management skills to create a team environmentIn-depth knowledge of the
FDA regulatory
environment for manufacture of pharmaceuticals, medical devices, and therapeutics.In-depth knowledge of
Production Quality,
Change Management, Supplier Quality, Non-Conformance investigations, Complaint management, and Document Control.Experience in risk management, tech transfer, validation, analytics, and microbiology and/or chemistry, within a GMP environment.Good leadership skills
to motivate plant personnel and gain their respectSkills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.Candidate Nice to Have:Advanced degree
or an
MBAExperience with
remediation of
Quality systems in FDA 483 or warning letter
situationKnowledge of
Sterile Aseptic Filling OperationsStartup or Small company experience working in a
dynamic and hands-on
role.Six Sigma, Lean Manufacturing , continuous improvement, etc.Comfortable and capable of gowning into an
ISO 7/ISO 8
manufacturing environmentContract Manufacturing
experience working closely with
customers and clientsKeywords:
BioPharma, Pharma, Quality, ISO, FDA, QA, QC, CMO, Sterile Aseptic, filling, BFC, remediation
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