Supervisor, QA Drug Product - Second Shift (Holly Springs)

This position supports a Monday-Friday 3pm-11:30pm shift schedule. In the future, this will shift to a 2/2/3 6am-6pm or 6pm-6am schedule.

The QA Operations Shift Supervisor is responsible for providing day-to-day supervision and risk-based QA support of the Drug Product Manufacturing area and processes.

What You’ll Do

• Provides day-to-day supervision of the Quality Assurance (QA) Operations Drug Product (DP) Team.
• Applies expertise in manufacturing QA concepts and business knowledge to act as primary point of contact for their team and first line escalation point in areas of their responsibility.
• Gathers recommendations for enhancements and gaps related to their area of responsibility and in collaboration with leadership prioritize and implement solutions accordingly.
• Maintains relationships with site-based customers and global colleagues and provide updates to leadership as requested.
• Ensures allocation of adequate resources for shop floor QA activities (e.g. BPR review, event triage, AQL), QA support activities (e.g. deviation/CAPA review and approval, clearance and area release), and technical QA activities (e.g. Change Control 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 DP material.
• Serves as Subject Matter Expert (SME) in audits and inspections for DP area.
• Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
• Provides training, coaching and mentorship of their team and peers as applicable. Works with their team to identify areas of improvement, reduce blind spots and give opportunities for increasing responsibility as appropriate for each individual’s career objectives.
• 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.
• Other duties, as assigned.

Knowledge, Skills, or Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly.
• Ability to think critically and have superior problem-solving skills, organization and planning skills.
• Team based attitude and ability to build relationships and communicate effectively with others.
• Positive attitude to embrace a dynamic work environment.
• Knowledge of Technology Transfer and/or Product Commercialization processes.
• Occasional opportunity for International and/or Domestic travel may be available.
• Ability to coach, lead, and develop individual contributors.
• Ability to effectively present information to others.
• This role supports a 24/7 operations environment and requires working nonstandard and rotating shifts, including nights, weekends, and holidays, as assigned. Upon hire, the position will be assigned to second shift on a 5x8 schedule and is eligible for shift differential in accordance with Company policy. The role is expected to transition to a 2-2-3, 12-hour rotating schedule, with shift differential eligibility per policy. The timing of the transition will be communicated in advance and is subject to business needs.

Minimum Requirements:

• Bachelor’s degree with 4+ years of experience from a similar role.
• 2+ years of team management experience.
• Experience leading, supervising, or managing others.
• Experience working in a regulated GMP environment.