Forge Biologics
Sr. Manager, Quality Assurance
Forge Biologics, Columbus, Ohio, United States, 43224
About Forge
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About The Role
The
Sr. Manager, Quality Assurance
is responsible for the development and management of the Quality Assurance team at Forge Biologics. The Quality Assurance team includes oversight of the GMP Manufacturing space as well as the laboratories. The Sr. QA manager will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. The Sr. QA Manager will also be responsible establishing and improving the internal Quality policies that provide oversight of the GMP manufacturing area.
What You'll DoMust be thoroughly knowledgeable with pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements / guidance documents.Partner with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.Serves as a quality resource for operations departments.Responsible to make prompt, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products including material disposition decisions.Effectively communicate to management Quality issues that arise during the manufacturing of product.Proactively identify and implement items to enhance quality through continuous improvement (CAPA)Responsible for the authoring or review and approval of investigations, CAPAs and change controls to drive for resolution through root cause analysis.Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc.Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management.Provide leadership in employee relations by fostering effective communication, offering coaching and training, supporting development, and removing obstacles to facilitate team progress.Supports internal and external audits as needed.What You'll Bring
Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).Experience in a Quality role in a GxP regulated industry.Direct experience in providing QA oversight for cGMP manufacturing operations.Knowledge of drug development regulations such as the GCPs, GMPs and GLPs.Previous leadership experience.Experience in supporting regulatory audits.Must be self-motivating, organized, and proactive.Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.Ability to effectively communicate quality issues to senior leadership.Strong interpersonal skills to work with a diverse team.Ability to work hours necessary to support production and/or product transfer activities.Ability to work in confined spaces and near operating equipment.Comfortable working onsite 5 days/week.Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
E NGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.
We've Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly Un FORGE ttable.
Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependentsFlexible PTO (plus 14 paid company holidays)Annual bonus for all full-time employees401(K) company matchFully-stocked kitchen with free food/drinks12 weeks of paid parental leave - additional discount programs include childcare support & dependent careEmployee Assistance ProgramWellness benefits (financial planning services, mental health counseling, employer paid disability)Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About The Role
The
Sr. Manager, Quality Assurance
is responsible for the development and management of the Quality Assurance team at Forge Biologics. The Quality Assurance team includes oversight of the GMP Manufacturing space as well as the laboratories. The Sr. QA manager will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. The Sr. QA Manager will also be responsible establishing and improving the internal Quality policies that provide oversight of the GMP manufacturing area.
What You'll DoMust be thoroughly knowledgeable with pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements / guidance documents.Partner with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.Serves as a quality resource for operations departments.Responsible to make prompt, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products including material disposition decisions.Effectively communicate to management Quality issues that arise during the manufacturing of product.Proactively identify and implement items to enhance quality through continuous improvement (CAPA)Responsible for the authoring or review and approval of investigations, CAPAs and change controls to drive for resolution through root cause analysis.Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc.Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management.Provide leadership in employee relations by fostering effective communication, offering coaching and training, supporting development, and removing obstacles to facilitate team progress.Supports internal and external audits as needed.What You'll Bring
Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).Experience in a Quality role in a GxP regulated industry.Direct experience in providing QA oversight for cGMP manufacturing operations.Knowledge of drug development regulations such as the GCPs, GMPs and GLPs.Previous leadership experience.Experience in supporting regulatory audits.Must be self-motivating, organized, and proactive.Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.Ability to effectively communicate quality issues to senior leadership.Strong interpersonal skills to work with a diverse team.Ability to work hours necessary to support production and/or product transfer activities.Ability to work in confined spaces and near operating equipment.Comfortable working onsite 5 days/week.Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
E NGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.
We've Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly Un FORGE ttable.
Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependentsFlexible PTO (plus 14 paid company holidays)Annual bonus for all full-time employees401(K) company matchFully-stocked kitchen with free food/drinks12 weeks of paid parental leave - additional discount programs include childcare support & dependent careEmployee Assistance ProgramWellness benefits (financial planning services, mental health counseling, employer paid disability)Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches