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VP, Quality

AGC Biologics

This is a Full-time position in Boulder, CO posted June 4, 2021.

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market.

Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia.

As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies.

We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time.

For more information, visit www.agcbio.com.
Summary
The Vice President of Quality is responsible for oversight of the Quality Assurance (QA), Quality Control (QC),?Quality Systems, Validation and Regulatory Compliance groups in support of the?Colorado?site at?AGC?Biologics.

The VP works closely with the?site?leadership team to develop and execute the corporate goals and objectives for?Colorado.?

The initial focus will be to get the facility operational and integrate it into the AGC Biologics QMS.?The?VP?is responsible for leading?Colorado?as a?late-stage?and commercial manufacturing?operations.

The VP is responsible for oversight of the site quality systems and?ensuring?overall GMP compliance with current regulatory requirements and guidelines.?
Principal Responsibilities
Provide leadership and direction to the?Colorado?Quality organization.?

Serve as an active member of the Global Quality Leadership Team.?

Serve as an active member of the?Colorado?site Leadership Team responsible for development and setting of site strategy and goals.?

Mentor and develop staff?members within?the organization.?

The VP of Quality holds final accountability for and decision making on the matters relating to GMP compliance for the site.?

Responsible for setting the overall strategies, tactics and directions of the site QA, QC, Quality Systems,?Validation?and Regulatory Compliance?departments?in alignment with the AGC Biologics QMS.

Decisions are focused on key strategic and operational maters that have significant, direction-setting impact on?the Colorado site.?

Responsible for setting and aligning goals and objectives for the QA, QC, Quality Systems,?Validation?and Regulatory Compliance?departments with the overall corporate goals and objectives.

Ensuring that the?site?goals and objectives are accomplished.

Failure to effectively execute responsibilities may negatively impact critical,?site-wide goals, objectives, and outcomes.

In addition, there may be legal and regulatory consequences.?

Accountable for development of QA, QC, Quality Systems,?Validation?and Regulatory Compliance?departmental budgets that support the corporate and departmental goals and objectives.

Responsible for controlling the budget during the fiscal year.?

Develops and drives Global Quality cross-site initiatives.?

Provides advice and counsel to the?site?Leadership Team on regulatory GMP compliance issues.?

Serves as the principal site spokesperson?with customers, regulatory agencies, etc., on matters of regulatory GMP compliance.?

Requires the ability to negotiate and achieve alignment with executive management and external audiences at the highest levels,?including regulatory?agencies.?

Works with other?AGC Biologics?sites to align and integrate quality systems.?

Other duties as assigned.?

Leadership Responsibilities
Mentorship responsibility?for Quality staff as well as peers?

Responsible for oversight of Quality staff?

Independently directs and controls the activities and outcomes of more than one major functional area, or a central, major corporate function with significant organization-wide impact?

Typically has sole responsibility for planning and managing a sizeable, highly discretionary budget?

Holds accountability for site?adherence?to all applicable quality regulations?

Knowledge, Skills & Abilities
20+ years of experience in biotech and/or pharmaceutical manufacturing?

15+ years of experience in quality operations (QA, QC, Quality Systems) within biopharmaceutical?and/or pharmaceutical industry?

Strong working knowledge of Quality Systems (FDA QSIT and ICH Q10) and how those systems are implemented to meet FDA and EMA requirements?

Experience supporting regulatory?filings (e.g., INDs, BLAs,?etc.) and leading product-related inspections for US and foreign regulatory agencies?

Experience developing, implementing and executing strategic plans and objectives for organizations and departments?

Exceptional customer interface skills are required?

Ability to work hours necessary to support operations activities?

Technical background in protein?development?is preferred?

Applicants must be authorized to work in the United States.

If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
Education/Experience
Requires?bachelor?or advanced?degree or equivalent combination of education and experience.

Equivalent education and experience may substitute for stated requirements
Compensation
$230,000 to $260,000
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

AGC Biologics is an equal opportunity employer.

All qualified applicants will?receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances