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Sr. Director of Quality

3 months ago

Lawrence, United States MRINetwork Jobs Full time

Job Description

Job Description

Our client – a growing company with multiple plants in the US, needs a

Sr.

Director of Quality

at their plant expanding to manufacture

pharmaceutical products . Excellent salary up to

$250K

+

Annual Bonus + Sign on Bonus + Relocation Assistance

+ Full Benefit Package +

4 Weeks’

vacation. Job Posting # 2648R

Job Title :

Sr. Director of Quality Location:

Lawrence, KS

Compensation:

Base of

$225K - $250K

per year + Annual Bonus

Target of 30% + Sign-On

Bonus

– $15K

Relocation:

YES - Client offers relocation assistance with a lump Sum sign on Bonus

Benefits:

Full package for medical, dental insurance,

401K

+

4 Weeks’

Vacation +

13 days

- PTO, etc.

Our client is a privately held company in business for

40 years

with manufacturing sites in

CA + KS

with around

300 people

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

Fill Finish Seal – FFS of Sterile Aseptic liquids.

This Quality group has around

25 people

from Quality control, Quality Assurance, Validation, Compliance and this position reports to the

Plant – General Manager.

Job Summary: The Senior Quality Director develops and deploys the quality system for a small to mid-size plant manufacturing Medical Devices and Pharma Biologics, 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: Manage the batch review and release activities 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 Develops budget for plant or

programs/department

and ensures adherence to the budget Manages overall coaching, training, development, and succession plans for the team Qualifications In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics Strong leadership skills and demonstrated success in managing a team. Capable to manage in matrix and ability to interact successfully with multi-functions globally Strong analytical, problem solving, and decision-making skills Excellent verbal and written communication skills Success working with multifunctional, global teams Excellent

interpersonal/communication/influencing/negotiation

skills required Extensive working knowledge of applicable quality and regulatory standards and regulations Experience in risk management, validation, analytics, and microbiology, within a GMP environment Quality expertise on tech transfer Comfortable and capable of gowning into an

ISO 7/ISO 8

manufacturing environment Candidate Must Have : Bachelors of Science or Engineering or related degree Min. 15 years

of experience in

Medical Device or Pharma

Industry Min. 5 years

of

Quality Management

experience in the

Pharma

Industry Excellent people, communication and management skills

to create a team 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

environment 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. Contract Manufacturing

experience working closely with

customers and clients Keywords:

BioPharma, Pharma, Quality, QC, QA, FDA, 483, Warning Letter, CMO, Sterile Aseptic, filling, FFS, Management, Validation, CDMO, Manufacturing, Plant,

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