Manager, Quality Assurance

Inotiv
US - Indiana - West Lafayette
November 30, 2024

Overview:

The Manager, Quality Assurance is responsible for the management of a Quality Assurance Program at their Inotiv site that encompasses the relevant aspects of appropriate federal regulations.
The QA Manager is responsible for coordinating the compliance activities at their facility by working with QA management/staff, and other related functional team members to assure compliance.
This position ensures that quality audit programs are in place to evaluate compliance with SOPs, protocols and relevant regulatory requirements.
The QA Manager will supervise QA staff in the execution of the audit program and review process and will manage regulatory inspections and sponsor audits.
The QA Manager may also be responsible for performing quality audits and process reviews.
In addition, the Manager Quality Assurance will evaluate the significance of audit findings and coordinate responses with Inotivs management as needed.

Responsibilities:

Design, develop, implement and manage the QA program to ensure compliance with all relevant regulatory requirements included but not limited to GLPs, particularly as applicable to medical device testing.
Ensure audit programs are in place to assess compliance with SOPs, protocols, and relevant national regulations.
Ensure quality assurance monitoring of all regulated studies conducted in the facility and make recommendations to management to address deficiencies.
Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance.
Manage regulatory and sponsor audits; make recommendations to management to address deficiencies.
Supervise and train QA staff to meet Quality Assurance goals.
Implement corporate policies, provide discipline, conduct personnel reviews, recommend adjustment of salaries and facilitate professional working conditions.
Provide regulatory training for all scientific staff members.
Assign and monitor daily projects for the quality assurance group.
Assure management that all work is conducted in accordance with Inotiv policies and procedures and applicable government regulations
Participate in in-house training programs for the technical staff
Maintain confidential information
Interact with the community and employees
Support and participate in other company initiatives as directed by senior management
Perform other duties as assigned

Qualifications:

B.
S/B.
A in a science related field with at least 5 years of direct GLP quality assurance experience in the pharmaceutical, contract research or medical device industry.
An advanced degree in science is highly desirable.
Supervisory experience required.
Relevant quality certifications preferred.

Skills and Abilities

Ability to use personal computers to write reports

Excellent written and verbal communication skills

Ability to comprehend and apply applicable government regulations

Ability to adhere to safety regulations and procedures

Ability to interact and problem solve with all quality assurance and scientific staff

• This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience.
The salary range will adjust along with the level of the role to match the persons relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we Play to Win in an industry rich with opportunity.
Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.
Theres an opportunity for everyone at all phase.

Read the full job description and apply online on the recuiter's web-site

Related Job Postings

Travel Nurse RN - PICU - Pediatric Intensive Care 2,361 per week

Care Team Solutions

US - IN - IN - Indianapolis
January 8, 2025

Care Team Solutions is seeking a travel nurse RN PICU - Pediatric Intensive Care for a travel nursing job in Indianapolis, Indiana. & Requirements • Specialty: PICU - Pediatric Intensive Care • Discipline: RN • Start Date: 02/03/2025 • Duration: 13 weeks • 48 hours per week • Shift: 12 hours •...

Find Jobs Hiring Now Near You!

Get Jobilize Job Search Mobile App Now