K.A. Recruiting


Quality Systems Leader (Bio/Pharma)

Ames, IA 50011

Job Type: Other Allied Healthcare Opportunities Job Number: NEC0983

Reference Code: NEC0983

Quality Systems Leader 

This individual will be responsible for Quality System Leader oversight and will develop, improve and execute Quality procedures. The candidate will be responsible for maintaining compliance in the CAPA program, including leadership in the area of product complaints, manufacturing investigations, change control, document control, training, corporate metrics and KPIs.  This role is a Quality Leader who provides team leadership according to company policies and corporate business plans.   The expectations of the role will also be an individual who actively identifies risk areas and implements process improvements and risk mitigation plans and develops individual and team competencies at the site
 
Key Leadership Responsibilities
 
Leader of site CAPA and complaints systems
Leader of site execution of Change Control System
Provide oversight of the controlled document management system
Generate and report monthly metrics
Monitor Quality backlog items and partner with stakeholders to ensure on time closure
Identify process improvement initiatives for optimization and compliance
Coordinate inspection back room activities and ensure timely completion of all requests
Prioritize work, resolve issues, develop and institute quality and efficiency improvements
Provide technical guidance, training and oversight for Quality Systems personnel
Supervise and develop personnel
 
Skills: 
 
Bachelor’s Degree in Science or related scientific degree
10 years recent experience in drug product, vaccine or biologics manufacturing
2 years of experience administrating a CAPA Program
 
Additional Skills/Preferences: 
 
Supervisory/Leadership experience at a highly regulated manufacturing organization
Expertise in the area of Quality Systems, including Change Control and CAPA
Business and technical competence, persistence/energy, planning and organizing, quality orientation and teamwork
Good understanding of the manufacturing requirements applicable to injectable/parenteral dosage forms
Proven project and people leadership skills
Formal Training and work experience in Quality Risk Management, lean manufacturing, and root cause analysis
Experienced in Interacting and communication with regulatory authorities in both written communication and inspection settings
 
Additional Preferences:
Masters Degree/Ph.D preferred
Lean 6 sigma black belt
Supervisory experience required in the area of biologics
 
If you are interested in this position please forward updated resumes to natalie@ka-recruiting.com for consideration 

Please click APPLY ONLINE or email us a copy of your resume directly (my email is next to my profile). Be sure to check out all of our jobs at http://jobs.ka-recruiting.com. We look forward to working with you!

Natalie Conklin
Healthcare Recruiting Manager

Thank you for taking the time to look at my current job openings. Natalie has specialized in working with allied healthcare professionals for over 7 years. As the Healthcare Recruiting Manager at K.A. Recruiting, she takes pride in building long-term relationships with both clients and candidates in order to address hiring needs as well as individual career goals for her candidates. She has worked with Physicians, Advanced Level Practitioners, Therapists, Nurses, Nurse Leaders, Laboratory, and other Allied Health candidates to assist them in securing permanent positions nationwide. Natalie has had a successful track record that is founded on the highest standard of quality combined with taking the time to personalize each candidate's job search to help them secure a long-term position. If you are looking for a full-time permanent position anywhere in the country I would love to hear from you! Please connect with me on LinkedIn Here:

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