Associate Manager, QA DSM Operations

Fujifilm•Holly Springs, NC

About The Position

The Associate Manager, QA Operations leads and supervises a team of QA professionals responsible for providing day-to-day risk-based QA support of Drug Substance Manufacturing areas and processes in a fast-paced, dynamic environment. This role is the primary point of contact for their team and the first-line escalation point in areas of their responsibility. This role collaborates with leadership, site-based customers, and global colleagues.

Requirements

BS in Life Sciences or Engineering and minimum 5+ years of relevant experience OR
MS in Life Sciences or Engineering and minimum 3+ years of relevant experience OR
Ph.D. in Life Sciences or Engineering and minimum 1+ years of relevant experience
2-4 years of people management experience
Experience working in a regulated GMP environment

Nice To Haves

Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software is a plus
Experience and understanding of the following processes preferred such as cell culture or fermentation
Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills
Training and/or familiarity with Quality Risk Management principles preferred

Responsibilities

Provides supervision of the QA Operations DSM Upstream team. Ensures allocation of adequate resources for shop floor QA activities (e.g., BPR review, event triage), QA support activities (e.g., DR/CAPA review and approval, changeover and area release), and technical QA activities (e.g., CC review and approval, WO oversight)
Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-size approach
Collaborates with Responsible Person(s) to facilitate timely disposition of DS material
Serves as Subject Matter Expert in audits and inspections for their area of responsibility
Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
Identifies and leads process optimization initiatives and continuous improvement tasks in their area of responsibility
Applies expertise in manufacturing QA concepts and business knowledge to act as the primary point of contact for their team and the first-line escalation point in areas of their responsibility
Gathers recommendations for enhancements and gaps related to their areas of responsibility and, in collaboration with leadership, prioritizes and implements solutions accordingly
Establishes a QC Sample Control laboratory including, but not limited to: SOP creation, training plan for team, inventory management, delivery of operational and inspection readiness goals, leading in both a project and routine operations environment
Maintains relationships with site-based customers and global colleagues and provides updates to leadership as requested
Administers company policies such as time off, shift work, and inclement weather that directly impact employees
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
Coaches and guides direct reports to foster professional development
Participates in the recruitment process and retention strategies to attract and retain talent, as needed
Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
Performs other duties, as assigned