-
Head of Quality
3 weeks ago
Andelyn Biosciences, Inc Columbus, United StatesOverview Of Andelyn Biosciences · Andelyn Biosciences · is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of · Columbus, OH , the company has expan ...
-
Head of Quality
3 weeks ago
Andelyn Biosciences Inc Columbus, United StatesOverview Of Andelyn BiosciencesAndelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH , the company has expanded to thr ...
-
Head of Quality
3 weeks ago
Andelyn Biosciences Columbus, United StatesOverview of Andelyn Biosciences · Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization.Located in the heart of Columbus, OH, the company has expanded to th ...
-
Head of Quality
3 days ago
Andelyn Biosciences Columbus, United States Full timeOverview of Andelyn Biosciences · Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to t ...
-
Head of Quality Management
3 weeks ago
The Ohio State University Columbus, OH, United StatesIf you have questions while submitting an application, please review these frequently asked questions . Current Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application pr ...
-
Head of Quality and Process Improvement
2 weeks ago
Jobot Columbus, OH, United StatesThis Jobot Job is hosted by: Dan Asher · Our client is a privately owned plastics packaging company in growth mode Join an industry leader in recycled packaging solutions. · Comprehensive medical/dental/vision benefits · Growth Opportunities · The Quality Supervisor role is r ...
-
Cascade Ventures Grandview Heights, United StatesWith 16 specialist clinics, 754 beds, subsidiaries kbs | The Academy for Health Professions at St. Kamillus GmbH and clinoserv gmbh, and approximately employees, we are an expanding maximum care hospital in Mönchengladbach and the surrounding area as an academic teaching hospital ...
-
Quality Specialist
3 days ago
Orion Innovations Whitehall, OH, United States Freelance**Quality Specialist (m/f/d) Quality Planning** · Location: Ihringen, Germany · **THE HELLA GUTMANN PROMISE** · Curiosity is our fuel. We know and understand the automotive industry like no one else. Our vast knowledge is brand, model, and technology-independent. We intelligently ...
-
Apex Ventures Gahanna, United StatesThe German Railway is not only one of the most important mobility service providers, but also one of the largest engineering offices in Germany. Currently, more than engineers work for us to realize and sustainably maintain new bridges, tunnels, train stations, tracks, and signal ...
-
Quality Manager
1 week ago
Imprimus Labels and Packaging Dublin, United StatesImprimus Labels and Packaging is a well-established, highly reputable leader in the label printing industry, with six manufacturing locations in California, Ohio, Tennessee, and Texas. We produce top-quality products for the demanding requirements of the cosmetics, personal healt ...
-
Department Head
2 days ago
SilverLion Inc Hilliard, United StatesThe Department of Human Resources and Internal Services at the Central Administration of the University of Tübingen is currently seeking a Department Head (m/f/d; A 14/E 14 TV-L, 100%) for the Department of Appointment Management and Personnel Budget, to be filled as soon as poss ...
-
Maintenance Manager
2 days ago
Omega Dynamics East Dublin, United StatesWe are looking for motivated employees for over 500 different professions, all across Germany. Whether you are an experienced professional or just starting your career, we offer numerous entry and training opportunities. · We are currently seeking a Maintenance Dispatcher (m/f/d) ...
-
Head of Sixth Form
2 weeks ago
The Protocol Group Ohio, United StatesWe are currently working closely with a college in the Nottinghamshire area to appoint their next Head of Sixth Form to be based in their Sixth Form Centre. · The Head of Sixth Form will oversee all aspects of our sixth form provision and lead on establishing the Centre as the fi ...
-
Skinner-Systems
3 weeks ago
Kysor Warren Epta US Corporation Columbus, United StatesJob Type · Full-time · Description · Cut, measure, and attach metal siding (skins) to refrigeration racks per customer specifications. Must be able to meet quality, safety, and efficiency standards for job/department. · Install siding on racks, often working in position of rea ...
-
Quality Assurance Manager
2 weeks ago
MRIGlobalFoodBev Ohio, United StatesMRIGlobalFoodBev is partnered with a syrups and sauces manufacturer that has a need for a Quality Manager in their Ohio site · Our client has been expanding into new markets throughout the country. This is a recent acquisition site which is enjoying a lot of reinvestment and supp ...
-
InsideHigherEd Columbus, United States Administrative Jobs ,Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr- If you have questions while submitting an application, please review these frequently asked questions. · Current Employees and Students:If you are currently employed or e ...
-
The Ohio State University Wexner Medical Center Columbus, OH, United States Full timeNationally Ranked Cancer Program Experiencing Significant Expansion - Head & Neck Oncologist · The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute expanded in December 2014 to become the 3rd largest can ...
-
Electronics Technician 3
1 week ago
M.C. Dean, Inc. Columbus, United StatesWe offer an excellent benefits package including · * A competitive salary · * Medical, dental, vision, life, and disability insurance · * Paid-time off · * Tuition reimbursement · * 401k Retirement Plan · * Military Reserve pay offset · * Paid maternity leave · Pay Range: $ $46.4 ...
-
Area Director of Restaurant Operations
2 weeks ago
Carlisle Columbus, United StatesA pioneering Wendy's franchisee, Carlisle's subsidiary Wendelta operates over 160 Wendy's restaurants in the Southeastern United States stretching from Texas to Florida and Louisiana to Tennessee. As an award winning company, Wendelta relies on Wendy's Founder Dave Thomas's five ...
-
Mental Health Specialist I
1 week ago
Nationwide Children's Hospital Columbus, United StatesOverview · Evening Shift 3:00pm-11:30pm every other weekend · hours) FTE · Every other weekend required; Benefits eligible. · Position starts at $19.387 an hour, plus $1.50 shift differential for evenings and $1.50 for weekends. · Pay to commensurate with relevant experience. · R ...
Head of Quality - Columbus, United States - BioSpace, Inc.
Description
Overview of Andelyn BiosciencesAndelyn Biosciences
is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization.
Located in the heart of
Columbus, OH , the company has expanded to three buildings with more than 250,000 combined square feet of space.
The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.
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 thedevelopmentand manufacturing of innovative therapies to bring more treatments to more patients.
ACCTS ions.
A
CCOUNTABLE
in our actions.
C
URIOUS
to discover.
C
OMPASSIONATE
in our thinking.
T
RUSTWORTHY
in our communications.
S
UPPORTIVE
of one another.
Employees are expected to perform the following essential functions under the framework of our
ACCTS ions.
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.
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.
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.
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.
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.
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
224 hours of Paid Time Off annually
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.
ACCTS.
#J-18808-Ljbffr