What are the responsibilities and job description for the Director/Associate Director, Quality Assurance Operations and Supplier Quality position at Ventyx Biosciences?

Description

Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases.

The Opportunity : Associate Director / Director, Quality Assurance Operations and Supplier Quality :

Reporting to the Sr Director of QA Operations and Supplier Quality, this role will be responsible for execution and management of Quality Assurance operations activities related to the company’s drug development activities across the entire portfolio. Activities will involve the application of industry GMP standards and strategies aimed at ensuring compliance with global regulations. This role will effectively collaborate cross-functionally at all levels of the organization as well as with external contract organizations and external regulatory authorities. This role will ensure strong quality oversight of contracted Drug Substance and Drug Product GMP operations, including but not limited to manufacturing, testing, packaging, labeling, and disposition globally.

What You Will Contribute :

Provide QA oversight for all aspects of GMP operations activities for Drug Substance and Drug Product including manufacturing, testing, packaging, labeling and disposition, ensuring compliance with cGMP standards, FDA, EMA, and other regulatory requirements as necessary.
Responsible for Drug Substance and Drug Product disposition.
Liaison in communications with QP involving EU release.
Responsible for alignment of disposition process with the deviation, investigation and change control processes including jurisdictional control of the finished drug product release.
Utilize Quality Management Systems daily in supporting root cause analysis, ensuring effective CAPA, approval of deviations and OOS / trend investigations, including responsibility for deciding final product impact and disposition.
Responsible for managing product complaints.
Provide QA review / approval for Drug Substance and Drug Product specifications and manufacturing and packaging batch records.
Execute supplier qualification and performance monitoring.
Support supplier audits as part of the supplier qualification program.
Develop effective and efficient working relationships with both internal and external partners.
Implement continuous quality improvement initiatives to ensure maximum productivity.
Develop and deliver presentations to executive management or external parties as needed.
Provide mentorship / guidance and collaborative partnership to cross-functional team members on Quality Assurance.
Remain current on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge.
Additional duties assigned as needed.

What We Seek :

8 years of quality assurance experience in the pharmaceutical industry in roles with increasing responsibility in quality operations and supplier quality required.

BS degree or equivalent experience in a scientific discipline or related field required.

Excellent leadership skills in supporting the company’s drug development efforts while ensuring all aspects of product and supplier quality.

Strong quality operations background to ensure value-added and effective quality operations.

Experience with performing vendor qualification audits.

Strong experience in quality oversight of Drug Substance, Drug Product and Packaging vendors for cGMP operations.

Strong expertise in investigations, root cause analysis, CAPA and change control processes.

Complete understanding and working knowledge of cGMP requirements for GMP manufacturing and global regulatory requirements.

Strong leadership skills, including demonstrated ability to build a team.

Strong analytical, problem solving, critical thinking, and decision-making skills, including an ability to combine attention to detail with a big picture perspective.

Excellent oral and written communication skills, including presentation and facilitation skills, to effectively communicate across different levels of organization.

Good presentation skills for diverse audiences.

Ability to strike a balance between independent work and team interaction, in a cross-functional work environment.

Strong interpersonal skills, with experience in interacting with and influencing people and building strong positive relationships.

Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems.

Experience authoring / reviewing regulatory and technical documents is a plus.

Ability to travel internationally up to 20% as needed.

What We Provide to You :

The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.

Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.

Competitive compensation and a comprehensive benefit package, including stock options.

The anticipated annual base salary range for this role is $170,000 - $245,000. Final compensation and level depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.

Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, age, ethnicity or national origin, color, religion, sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, sexual orientation, disability or medical condition (including genetic information or characteristics or those of a family member), military service or veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

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Salary : $170,000 - $245,000

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Director/Associate Director, Quality Assurance Operations and Supplier Quality

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