Top 22 Head of quality onsite Jobs in Columbus

Head of Quality - Onsite
Andelyn Biosciences, Inc —Columbus, OH
- Full-time
- Microsoft Excel
- Master's degree
- Bachelor's degree
- Paid parental leave
- Paid holidays
Quick Apply
Advanced Medical Support Assistant- Community Care
US Veterans Health Administration —Columbus, OH
- $51,747 - $67,271 a year
- Part-time
- Hybrid work
- Background check
- High school
- Pass drug screening
- Paid parental leave
- Paid holidays
2d
Training Manager
Event Risk Inc —Lewis Center, OH
- $90,000 - $110,000 a year
- Full-time
- 5 years
- Mid-level
- Travel
- Health insurance
- Dental insurance
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D.C. Operations Manager
Luxe Redux Bridal —Columbus, OH
- From $90,000 a year
- Online Application
- Background check
- Mid-level
- Analysis skills
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Community Manager
Asset Living —Columbus, OH
- $75,000 - $80,000 a year
- Overtime
- Mid-level
- Ability to climb stairs
- High school diploma or GED
- Paid holidays
- Disability insurance
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4d
Area Manager
JSI Janitorial, LLC —Columbus, OH
- Full-time
- Spanish
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Manager of Maintenance and Automation Solutions
Abercrombie & Fitch Co. —New Albany, OH
- Full-time
- Travel
- Mentoring
- Contracts
- Store discount
- Paid parental leave
Senior Business Development Manager Ericsson Mobile Financial Services
Ericsson —Westerville, OH
- $149,600 - $202,650 a year
- 8 hour shift
- Hybrid work
- Up to 50% travel
- Office
- 8 years
- Paid parental leave
- AD&D insurance
Data Center Security Installation Project Superintendent (Superintendent 1) - Columbus, OH
M.C. Dean, Inc —Columbus, OH
- $93,840 - $129,030 a year
- Weekends as needed
- Microsoft Word
- CPR Certification
- Construction site
- Paid parental leave
- Disability insurance
Estimator
Quanta Infrastructure Solutions Group, LLC —Columbus, OH
- Full-time
- 5 years
- Office
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
Sr. Electrical Design Engineer, Data Center Design Engineering
Amazon Data Services, Inc. —Columbus, OH
- $136,600 - $184,800 a year
- Full-time
- 6 years
- Engineering
- Maintenance
- AD&D insurance
- Health insurance
Certified Medical Assistant
LOWER LIGHTS CHRISTIAN HEALTH CENTER INC —Columbus, OH
- $17 - $21 an hour
- Full-time
- CPR Certification
- Writing skills
- Medical office experience
- Paid holidays
- Health insurance
Quick Apply
Mow Team Driver
Rine Landscape Group —Columbus, OH
- $21 an hour
- Full-time
- Clean driving record
- Mid-level
- Residential
- Health insurance
- Dental insurance
Quick Apply
Estimator
Quanta Services —Columbus, OH
- 5 years
- Office
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
Sr. Electrical Design Engineer, HVMV Engineering
Amazon Data Services, Inc. —Columbus, OH
- $136,600 - $184,800 a year
- Full-time
- OSHA
- Engineering
- Research
- AD&D insurance
- Health insurance
Landscape Enhancement Team Leader
Rine Landscape Group —Columbus, OH
- $22 an hour
- Full-time
- Clean driving record
- Construction site
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Field Service Technician
Flanders Electric Motor Service Inc —Columbus, OH
- $33 - $38 an hour
- Full-time
- Mid-level
- Forklift
- High school diploma or GED
Quick Apply
Senior Denials Prevention Process Improvement Advisor
Ensemble RCM LLC —Columbus, OH
- $69,000 - $104,100 a year
- Full-time
- Research
- Office
- Master's degree
- Tuition reimbursement
6d

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Head of Quality - Onsite

Andelyn Biosciences, Inc -
Columbus, OH

Quick Apply

Job Details

Full-time

Benefits

Paid parental leave
Paid holidays
Disability insurance
Health insurance
Dental insurance
Tuition reimbursement
Paid time off
Adoption assistance
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Loan assistance
Life insurance

Qualifications

Customer communication
Confidential information handling
Microsoft Excel
Data reporting
Metrics Reporting
Productivity software
Excel data analysis

Full Job Description

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

Our Values are founded in our origin story.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

What you will do.

The Head of Quality is the lead position of the Quality and Regulatory Organization and a member of the leadership team. The Head of Quality will provide strategic and operational leadership to establish, improve, and maintain the quality systems, policies, standards, and procedures. The Head of Quality is to ensure compliance with current US FDA, EMA, and relevant ICH guidance documents. Ensure the Quality Organization is appropriately resourced and effectively executing a required state of quality and CGMP compliance. The role includes the management of all quality oversight activities related to internal and external manufacturing, contract release and stability testing, and raw material suppliers. The Head of Quality is responsible for ensuring the Quality Organization is adequately staffed in Quality Assurance (QA), Quality Control (QC), Contamination Control, and Regulatory Affairs by attracting and hiring experienced professionals, developing talent, and empowering the team. The Head of Quality will be recognized across different functions as a partner and will continue to build a quality culture within the organization. The Head of Quality is a recognized role model by providing guidance and coaching to all levels within the Quality Organization and the leadership of the company.

Establish quality strategies to ensure cGMP compliance with US FDA, EMA, and other international regulatory agencies' regulations and expectations.
Direct and oversee the quality planning and execution processes.
Develop short and long-term plans to achieve both quality and business objectives for the organization.
Develop a quality policies strategy consistent with current regulatory expectations for rare diseases and ensure that the quality policies and objectives are clearly communicated, implemented, and maintained within the organization.
Ensure quality systems and processes are appropriate for the development stage of the product and the clinical and commercial application as appropriate.
Ensure manufacturing, testing and release, and distribution of gene therapy products are consistent and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards, and regulatory guidance.
Develop quality metrics and indicators to proactively identify and address quality systems or product-related issues.
Establish and lead a Quality Management Review (QMR) process to ensure continued compliance with CGMP standards.
Interface directly with the FDA, EMA, other regulatory authorities, and customer clients to ensure the company is appropriately represented in all matters related to compliance and quality.
Direct communications with the regulatory authorities as appropriate
Exercise discretion, judgment, and personal responsibility.
Demonstrate a high level of integrity.
Maintain a positive attitude.
Attention to detail in all job functions.
Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed.
Develop strategic planning and guidance for their functional unit in alignment with the overall organization and influence organizational strategic planning on an executive level.
Develop and define measurable objectives for the staff within their functional units to fit the objectives of the overall organization. Also is involved in organizational objectives on an executive level.
Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to ensure high productivity and contribution to the success of organizational goals.
Ultimate oversight on the development and enforcement of procedures and controls.
Establish a strategic process to control work procedures.
Complete budgetary control over the functions under their control also influences organizational budget establishment.
Some travel is required.
Responsible for hiring, development, and related personnel processes.
Mentoring and professional development of staff
Make use of essential people skills, including the ability to develop subordinates.
Ability to manage and influence people in direct and lateral support structures.
Ultimate decision-making latitude within their functional units and influences decisions on an organizational level.
Drives timelines and development through broad influence
Ultimate interaction with legal services
Develop and direct short and near-term goals.
Responsible for developing a 3–5-year business plan.
Responsible for Revenue (P&L)
Interprets Regulations for application within their functional unit.
Has business acumen and considers business impacts in planning and problem-solving.
Responsible for business development
Other duties as assigned.

What you bring to the team.

Must possess a relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred.
Expert business knowledge with a comprehensive understanding of the organizational and functional area.
Advanced Leadership skills
First-level executive responsible for a sub-set of a functional area or responsible for division-level
Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
Must possess a client-focused mindset in daily tasks.
Must possess prior experience handling confidential information and the ability to maintain confidentiality.

What you can expect when working at Andelyn.

The pride in contributing to the development and manufacturing of lifesaving therapies
The invaluable experience of being a part of building the foundation of a new organization
The opportunity to work alongside experts who have over 10 years in the gene therapy field.
Competitive compensation
Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid
160 hours of Paid Time Off annually, increases to 200 hours after 4 years of service
11 Company Paid Holidays plus 2 floating holidays annually.
Company Paid Life Insurance
401(k) Match
Company Paid short and long-term disability.
4 weeks of Paid Parental Leave for birth and adoption
Adoption Assistance
Tuition Reimbursement and Student Loan Repayment Assistance
Company Paid LinkedIn Learning access.
Employee Assistance Programs
Flexible work options (role specific)

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.

Quick Apply

Refine Your Search

head of quality onsite jobs in columbus

Head of Quality - Onsite

Advanced Medical Support Assistant- Community Care

Training Manager

D.C. Operations Manager

Community Manager

Area Manager

Manager of Maintenance and Automation Solutions

Senior Business Development Manager Ericsson Mobile Financial Services

Data Center Security Installation Project Superintendent (Superintendent 1) - Columbus, OH

Estimator

Sr. Electrical Design Engineer, Data Center Design Engineering

Certified Medical Assistant

Mow Team Driver

Estimator

Sr. Electrical Design Engineer, HVMV Engineering

Landscape Enhancement Team Leader

Field Service Technician

Senior Denials Prevention Process Improvement Advisor

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