Top 14 Director core laboratory services Jobs in Columbus

Senior Director Quality Affairs
American Regent, Inc. —New Albany, OH
- Weekends as needed
- 11+ years
- Master's degree
- Bachelor's degree
Technical Service Director
Franklin International —Columbus, OH
- $110,000 - $160,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Mentoring
- Health insurance
- Dental insurance
Quick Apply
Batch Maker I - Union
A Meridian Adhesives Group Company —Columbus, OH
- $31.55 an hour
- Clean driving record
- Basic math
- English
- Paid parental leave
- Health savings account
14d
Researcher 2 - Comprehensive Cancer Center
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Background check
- Pass drug screening
- HIPAA
Assistant/Associate Professor- Clinical track, Maxillofacial Prosthodontist
The Ohio State University —Columbus, OH
- Email
- Background check
- Pass drug screening
- Clinic experience
- Health insurance
- Dental insurance
Project Manager
Upland Mechanical, Inc. —Columbus, OH
- $105,000 - $175,000 a year
- Full-time
- Construction site
- Sales
- Computer literacy
Director of Antibody Therapeutics (Professor)
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Background check
- Medicine
- Pass drug screening
- Health insurance
- Dental insurance
Family Medicine Nurse Practitioner - Whitehall
BASECAMP RECOVERY LLC —Columbus, OH
- Full-time
- Spanish
- Nursing
- Psychiatry
- Mileage reimbursement
Quick Apply
Open-Rank Tenure-Track Faculty of Anesthesiology
The Ohio State University Wexner Medical Center —Columbus, OH
- Online Application
- Background check
- Medicine
- Surgery
- Health insurance
- Dental insurance
Family Medicine Nurse Practitioner
Basecamp Recovery Center —Columbus, OH
- $119,000 a year
- Full-time
- Spanish
- Nursing
- Psychiatry
- Mileage reimbursement
Quick Apply
Wildlife Rehabilitation Veterinary Technician (Certified RVT)
Ohio Wildlife Center —Powell, OH
- $21 - $22 an hour
- Part-time
- Background check
- Clean driving record
- Mid-level
Quick Apply
Assistant Director of Nursing - Behavioral Health
The Recovery Village —Columbus, OH
- From $83,200 a year
- Full-time
- Nursing
- RN License
- Mid-level
- Health savings account
- Paid holidays
Quick Apply

Other jobs to consider

Find your next job by exploring related positions.

Senior Director Quality Affairs
American Regent, Inc. —New Albany, OH
Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities…
Researcher 2 - Comprehensive Cancer Center
The Ohio State University Wexner Medical Center —Columbus, OH
Optimize workflows and ensure quality and compliance with institutional, state, and federal regulations (IRB, IBC, HIPAA, biosafety).

Show more related jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Senior Director Quality Affairs
American Regent, Inc. —New Albany, OH
Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities…
Technical Service Director
Franklin International —Columbus, OH
Assists and advises the CPD lab and technical service department on proper process, documentation and chemical specification agreements.
$110,000 - $160,000 a year
Quick Apply

Show more jobs in cities nearby

I want to receive the latest job alert for director core laboratory services in columbus

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

director core laboratory services jobs near columbus

Technical Director jobs in Columbus, OH

Director Of Quality jobs in New Albany, OH

Professor jobs in Columbus, OH

Family Nurse Practitioner jobs in Columbus, OH

Faculty jobs in Columbus, OH

Director Of Behavioral Health jobs in Columbus, OH

Batch Maker jobs in Columbus, OH

Project Manager jobs in Columbus, OH

Director Of People & Culture jobs in Chicago, IL

Technical Director jobs in Fort Lauderdale, FL

Technical Director jobs in Texas

Director Of Operations jobs in Fort Worth, TX

Athletic Director jobs in Providence, RI

Technical Program Manager jobs in Philadelphia, PA

Technical Director jobs in West Virginia

Technical Director jobs in Long Beach, CA

Director Of Quality jobs in San Antonio, TX

Director Of Quality jobs in North Carolina

Special Education Director jobs in Georgia

Director Of Quality jobs in Indianapolis, IN

Senior Director Quality Affairs

American Regent, Inc. -
New Albany, OH

Apply Now

Job Details

Full-time

Qualifications

Customer communication
Program management
Drug regulation
Manufacturing facility experience
Production validation processes
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Regulatory/legal compliance standards in production
Cleanroom experience
Quality control experience within pharmaceutical industry
Senior leadership
Pharmaceutical manufacturing facility experience

Full Job Description

Nature and Scope

Reporting to the Senior Director of Quality is a multi-disciplinary management role that will interact with all phases of production for the manufacture of sterile injectables. This position is responsible for oversight and direction for all aspects of compliance including laboratory operation, documentation, Regulatory Body Inspections (e.g., FDA, Health Canada, etc.), supplier quality, third party manufacturer quality, as well as strategic quality initiatives and continuous improvement processes. This position will interact with all levels of the organization both domestically and internationally.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Provides Leadership and direction for a professional team focused on quality management systems and compliance; establish and maintain performance goals, training plans, and provide regular feedback including performance plans and reviews.
Perform all duties in accordance with American Regent’s Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
Quality Management Ownership for Deviation, CAPA, Change Control, Documentum Control, Annual Product Review Systems, Technical Services and External Manufacturers (CMO’s).
Lead Quality activities to execute production records, approve executed batch records, and support release of product for shipment.
Manage and improve ARI’s Quality Systems to ensure compliance with regulatory requirements and provide safe and effective products to customers.
Ensures site wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory requirements.
Identify and facilitate the resolution of quality issues in conjunction with site teams.
Manage all aspects of regulatory authority inspections, and customer and corporate audits, development of responses, and execution of required improvements following such inspections/audits.
Own and support metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPI) through application of statistical methodology.
Provide oversight for review and release of commercial, R&D, and clinical study products.
Responsible for maintaining and managing communications and cross-functional activities with internal/external customers and regulatory agencies.
Responsible for continuous improvement initiatives for the site and working with other ARI locations to assure best practices and harmonization of policies and procedures.
Drives quality Culture and Core Competency Model initiatives in support of enhanced organizational performance.
Responsible for Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site.
Manage and facilitate the QA Operations, QA Inspection and Finishing team to assure timely and quality oversight of production activities related to production, manufacturing, filling and transfers, inspection and packaging of sterile injectable drug products.
Partner with Production, Regulatory Affairs, Engineering, R&D and QA Compliance to strategize and organize implementation of new technology, processes and products.
Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated with daily inspections/packaging operations.
Write and revise SOP’s and other cGMP documentation.
Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements.
Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Bachelors in Life Science or equivalent course of study required. Master’s Degree is a plus.
Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.
Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.

Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facility.
Understands the standards and principles of Compliance and Quality Assurance including the specific regulatory requirements and techniques of examining, questioning, evaluating and reporting to determine a quality system’s adequacy and deficiencies.
Must have a thorough understanding of applicable regulations/guidelines/expectations and have a proven ability to apply them to a Pharmaceutical environment.
Proven excellence in written and verbal communication skills.
Proven record of exceptional people and program management skills.
Ability to work independently and deliver timely results.
Ability to work off hours and weekends as needed.
Able to travel 10% of the time.

Physical Environment and Requirements

While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

Employee must be able to occasionally lift and/or move up to 25 pounds.
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
Our recruiting process includes multiple in person and/or video interviews and assessments.
If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].

Apply Now

Refine Your Search

director core laboratory services jobs in columbus

Senior Director Quality Affairs

Technical Service Director

Batch Maker I - Union

Researcher 2 - Comprehensive Cancer Center

Assistant/Associate Professor- Clinical track, Maxillofacial Prosthodontist

Project Manager

Director of Antibody Therapeutics (Professor)

Family Medicine Nurse Practitioner - Whitehall

Open-Rank Tenure-Track Faculty of Anesthesiology

Family Medicine Nurse Practitioner

Wildlife Rehabilitation Veterinary Technician (Certified RVT)

Assistant Director of Nursing - Behavioral Health

Other jobs to consider

Explore jobs in cities nearby

I want to receive the latest job alert for director core laboratory services in columbus

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected