Senior Manager, Quality Systems

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. 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, visitwww.agcbio.com.

The SrQuality Systems Manager oversees quality management systems (Change Control, CAPA, Change Management, Complaints and/or Recall) for a team. Monitors compliance with established processes and to applicable regulatory guidelines/requirements.

• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
• Routinely develops guidelines for less experienced employees to accomplish work independently.
• Recommends changes to policies and establishes procedures that affect immediate organization(s); manages development and implementation of tactical initiatives.
• Management reviews to measure meeting of objectives.

Key Responsibilities

• Manage Quality Systems for a team.
• Manage the development and maintenance of site documentation, procedures, work instructions, and templates related to Quality Systems.
• Review and approve the required quality system documents and document change requests, document workflows, and release documents associated.
• Develop and deliver quality system tools and system changes.
• Support and manage internal audits, and external audits.
• Develop and deliver routine and ad hoc metric reporting and analysis.
• Responsible for QMS system function; escalate issues to IT/Quality System management as necessary.
• Determine timing and provide updates of deliverables to customers, management, and stakeholders.
• Manages daily operations for a project/team comprised of professional employees.
• Prioritizes and assigns technical resources internally and externally; ensures tasks are completed and work area/project goals and objectives are met.
• Coordinates and collaborates with other teams to meet organizational goals and work requirements.
• May coach and develop team members on skill proficiency and performance with general direction on tasks and regular feedback.
• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and is able to identify viable and often innovative options
• Uses analytical skills and judgment to recommend a "best" solution.
• Acts as advisor to less experienced colleagues to meet schedules and/or resolve technical problems.

Knowledge, Skills, And Abilities Required

• Requires understanding of how the team/work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact.
• Identifies and resolves technical, operational and organizational problems/problems relating to own discipline.
• Frequently works cross-functionally as the representative for their area.
• Decisions impact others in the immediate team and influences methods and techniques used.
• Frequently interacts with subordinate supervisors, and/or functional peers, normally involving matters between teams or functional areas
• Often must lead a cooperative effort among members of a project team/work area; works to build consensus
• Able to effectively communicate data-driven results and recommendations to senior leaders of all functions at all levels within the company
• Networks with key contacts outside own area of expertise
• Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing.
• In some instances, may manage a functional area without any direct reports.
• Begins to play a hand in professional development of others; may mentor less experienced employees on job duties and general departmental operations.
• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors.

Education & Experience

• BS/BA degree with 8+ years of industry experience, or
• Master's degree with 6+ years of industry experience. Equivalent education and experience may substitute for stated requirements.

COMPENSATION RANGE:

$129,500 - $170,940

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

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.