Director of Quality - Lawrence, United States - MRINetwork Jobs

Description

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 - Pharmaceutical

Location:
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

100employees

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 policies
Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirements
Drives 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 improvements
Interacts frequently with all levels of internal management as well as across functions and franchises
Manages interactions with customers and regulators concerning the quality of products, systems, and processes
Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility

Candidate Must Have :
Bachelors of Science in Chemistry, Microbiology, Engineering

or related degree
Min. 10 years

of experience in

Medical Device or Pharma

Industry
Min. 5 years

of

Quality Management

experience in the

Pharmaceutical

Industry
Excellent people, communication and management skills to create a team environment
In-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 respect
Skills 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


MBA
Experience with

remediation of

Quality systems in FDA 483 or warning letter

situation
Knowledge of

Sterile Aseptic Filling Operations
Startup 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 environment
Contract Manufacturing

experience working closely with

customers and clients

Keywords:
BioPharma, Pharma, Quality, ISO, FDA, QA, QC, CMO, Sterile Aseptic, filling, BFC, remediation

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