The Opportunity:
We're seeking a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project based at the Holly Springs site. The successful candidate will lead operational readiness, compliance, training and continuous improvement efforts for the Assembly and Packaging function at the Holly Springs facility. The position transitions from initial site startup strategy—focusing on SOP lifecycle, risk management, MES batch records, and operational and regulatory readiness—to post go-live leadership over deviation management, RCA, change controls, continuous improvement, metrics governance, and team development.
Key Start-up Responsibilities:
- You will oversee the authoring, review, and lifecycle strategy for manufacturing-centric standard operating procedures (SOPs), work instructions, and critical documentation for the Assembly and Packaging area.
- You will drive proactive risk management initiatives to identify operational risks and inefficiencies in new processes and establish strategic mitigation plans prior to operational impact.
- You will provide strategic oversight for the governance, validation, and approval framework of manufacturing batch records within the MES system.
- You will lead the strategy and framework for learning and technical capability development across the A&P team.
- You will direct the investigation governance and ownership for major/minor deviations and third-party nonconformances.
- You will serve as the primary change management lead, driving evaluation, approval, and execution of change controls across functional areas.
- You will lead initial regulatory inspection readiness, representing the site as a senior SME and functional point of contact for Assembly and Packaging.
Post Go-Live Responsibilities:
Following the facility's go-live, you will transition to lead the P&C Business Unit. In this sustained operations phase, you will:
- You will lead, mentor, and build high-performing P&C team members to foster technical excellence and operational capability.
- You will provide oversight and accountability for major and minor deviations, including partner and third-party manufacturing investigations.
- You will drive the continuous improvement portfolio, governing compliance actions, document updates, and strategic process enhancements.
- You will champion complex Root Cause Analysis (RCA) investigations and lead cross-functional problem-solving efforts for critical operational issues.
- You will oversee the end-to-end change control process to support business evolution and regulatory compliance.
- You will lead health authority regulatory inspections as a key site presenter, process lead, and strategist for regulatory responses and commitments impacting the Assembly and Packaging area.
- You will establish and govern departmental metrics, KPIs, and executive reporting cadence to accelerate continuous improvement and business alignment.
- You will cultivate an inclusive, high-performing team culture focused on operational excellence, quality, and high accountability.
- You will direct cross-functional alignment and issue resolution across operational areas (assembly and packaging), site leadership, and cross-site initiatives.
Who you are:
- You have a BS/MS degree in Science or Engineering with 12+ years of deep, relevant bio/pharmaceutical manufacturing, quality, or engineering experience.
- You have practical knowledge of device assembly and packaging equipment, processes, and materials/components.
- You have at least 5+ years experience as a deviation owner, using root cause analysis tools such as “5 Whys”, “Fault Tree Analysis” and “Fishbone”.
- You have 2+ years experience managing change controls.
- You have a demonstrated ability to lead effectively cross-functional and multi-disciplinary teams, and collaborate with colleagues across different functional departments (Operations, Engineering, QA, Supply Chain, Safety, etc.) to enable collective progress across the organization.
- You have experience in working in an FDA regulated bio/pharmaceutical environment, and a strong understanding of cGMP regulatory requirements related to manufacturing processes in the pharma industry.
- You have strong analytical and problem-solving abilities to identify and resolve process-related issues. You are able to lead complex problem solving efforts, investigate root causes, and propose effective solutions to ensure efficient operations and compliance with regulatory requirements.
Preferred:
- You have experience with Veeva QMS and Veeva QDocs
- You have advanced project management skills
- You have experience with high volume fully automated device assembly and packaging and greenfield project experience.
The expected salary range for this position based on the primary location for this position is $116,000 - $217,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Link to Benefits
This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.
