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Associate Director - Quality Control

Employer
Andelyn Biosciences
Location
Columbus, OH
Start date
Nov 3, 2023

View more

Discipline
Quality, Quality Control
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

It’s an exciting time to join us!

The Andelyn Biosciences’ Quality Control group is seeking a motivated individual to join our growing team as a Associate Director – Quality Control

The AD of Quality Control will be responsible for all aspects of the Quality Control laboratory, including but not limited to material, in-process and release testing, stability testing, contract lab testing, Micro/EM testing. The AD of QC will assist in team management to support externally sourced projects and quality events. He/She should be able to perform in-depth laboratory investigations based on regulatory guidance and scientific understanding.  We are looking for a detail-oriented, quality-minded person who can make critical decisions independently and promptly. The AD of QC will act as an interdepartmental liaison to various groups, including Analytical Development, Manufacturing, and Quality Assurance. AD of QC should have some expertise in technical writing and Investigations.  He/She should exercise judgment and maintain a high level of compliance with applicable procedures, standards, and alignment with GxP regulations.  He/She must deliver all deliverables in a timely manner.  He/She must have sense of urgency client facing attitude.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Corporate Center (ACC)

                  1180 Arthur E. Adams Dr.

                  Columbus, OH 43221

 

Under the guidance and direction of the Head of Quality essential functions of the Associate Director – Quality Control includes at a minimum:

  • Provide oversight of Quality Control operations
  • Provide oversight for training personnel and management of training processes and content
  • Represent Quality Control and company during client and regulatory audits and assist in responding to any findings
  • Provide management coordination of various compliance documentation such as laboratory investigations, deviations, CAPAs, audits, change controls, validation & technical study protocols, and other cGXP compliant documentation
  • Provide management coordination of Testing (routine and validation)
  • Perform Management Review and Approval function for technical studies and notebook studies, developmental results, method validation protocols (IQ, OQ, PQ), and SOPs
  • Ensure compliance with the cGMPs regulations and current procedures.  He/She must remain current with the changing regulatory requirements
  • Conduct lab audits and participates in implementing lab improvement to ensure GMP compliance
  • Communicate metrics, trends, and data summaries to senior management as part of Management Review, using a variety of media: intranet, reports, and presentations
  • Maintain metrics within predetermined limits
  • Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements
  • Manage employees with various experience levels with the capability to develop new leaders, individual contributors, and technical experts
  • Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to the group
  • Along with other QC team members, manage product release testing activities at CMOs and contract labs to ensure the highest quality data is received on time to meet client’s expectations. This includes programs such as raw materials and reference standards
  • Participates in investigations related to assay failures, system deficiencies, deviations, and equipment/assay troubleshooting
  • Participates in transferring and qualifying methods and procedures for new assignments as required
  • Oversight of analytical method qualification, validation, and transfer into and out of the QC lab with QC team
  • Manages projects in collaboration with other team members, both internally and at external sites
  • Coach and mentor staff in all aspects of their job performance and career development
  • Maintain the QC lab and relevant documentation in inspection ready state all the time.
  • Help to establish the QC laboratory, including aspects related to facilities, instruments, processes, and procedures
  • Prepare quality documents e.g., SOPs, technical documents, Investigations, review, and approvals
  • Review/approve all quality system records such as OOS/OOT investigations, laboratory deviations, change controls, and CAPAs
  • Update and maintain trending files, and provide routine summaries of trending to support investigations
  • Responsible for resource management and initiating timely resource planning for the QC team based on production forecasts and business needs
  • Appropriately analyze data, interpret results, and maintain accurate laboratory records; prepare and deliver presentations at team meetings
  • Develop plans and timelines with clients, provide routine client updates, and deliver timely contracts
  • Support transfer of methods to/from collaborators or internal development members
  • Oversight of GMP release and stability testing of biotherapeutics products
  • Responsible for raw material and critical reagent management, including vendor selection/qualification and release testing
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate a high level of integrity
  • Maintain a positive attitude
  • Attention to detail in all job functions
  • Follows established policies, procedures, and techniques and acquires training experience and working knowledge related to the tasks performed
  • Develop strategic planning and guidance for their functional unit in alignment with the overall organization. Influences 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
  • Cultivates 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 development and enforcement of procedures and controls
  • Establish a strategic process to control work procedure
  • Complete budgetary control over the functions under their control also influences the organizational budget establishment
  • Frequent travel may be 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 the direct and lateral support structure
  • 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
  • Develops and directs short and long-term goals
  • Interprets Regulations for application within their functional unit
  • Has business acumen and considers business impacts in planning and problem solving
  • Other duties as assigned

 

Knowledge, Skills and Abilities required:

  • Must possess relevant four-year degree OR relevant Masters OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
  • Broad knowledge of the field with proven leadership skills
  • Prior management experience is required
  • Broad knowledge of the scientific basis of analyses being performed.
  • Full understanding of techniques used in the QC laboratory
  • Second-level manager.  Manages the activities of first-level managers and/or supervisors
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
  • Proficient knowledge of current regulations and guidance documents including cGMP, ICH, USP, EP and other applicable regulatory guidance (US and EU), and experience with regulatory agency inspections.
  • Knowledge of analytical methodologies such as liquid chromatography, diverse PCR technologies, Microbiology, and applying/interpretation of GMP requirements.
  • 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

 

Minimum Physical Requirements:

  • Frequently Sitting
  • Frequently Walking/Standing/Stooping
  • Occasionally Independently lifting up to 50 pounds
  • Constantly Talking on the phone or in-person
  • Constantly Typing on a computer keyboard

                                                                       

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.  It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.

Company

Andelyn Biosciences is a biopharmaceutical CDMO Pioneering Solutions That Turn Hope into Reality™. With 20+ years of experience manufacturing viral vectors, Andelyn's scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. The name "Andelyn" is a hybrid of two gene therapy pioneers 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, representing all the families who have courageously participated in the research that make today's gene therapies possible. Continuing Andelyn's patient-based mission, the company is opening two state-of-the-art commercial manufacturing and development sites. The Dublin-based Andelyn Development Center is set to open in May 2022 and will house Andelyn's preclinical and development services. The 185,000 square foot Andelyn Corporate Center located on The Ohio State University's Innovation District will open for production in mid-2022.  

Company info
Website
Phone
614-580-8522
Location
1180 Arthur E. Adams Dr.
Columbus
OH
43221
United States

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