Senior Manager, External Manufacturing & Development Services
Listed on 2026-07-07
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Business
Regulatory Compliance Specialist, Operations Manager
Position Overview
Blue Rock Therapeutics is seeking an External Manufacturing & Development Services, Senior Manager to support External Partners activities. The Senior Manager will manage the operational relationship with Blue Rock’s External Partners, facilitate cross‑functional discussions, and own operational activities such as KPIs, budget, and contract management. This role reports to the Director, External Manufacturing & Development Services.
Responsibilities- Own the relationship with assigned ExPs and act as key point of contact for Blue Rock.
- Responsible for overall ExP performance and project execution including budget and timeline adherence.
- Lead and action issue resolution to mutually beneficial outcomes.
- Own annual forecasting, planning, and resource allocation with ExPs in collaboration with Blue Rock functional groups.
- Lead cross-functionally operational meetings with assigned ExPs to drive improvements in collaboration, quality, and performance.
- Act as escalation contact for performance remediation.
- Negotiate and manage ExP related contracts (MSA, SOWs, QAAs).
- Own risk management and continuous improvement activities within the ExP network in collaboration with Blue Rock QA and operational teams.
- Work closely with Blue Rock workstream leads to identify ExP‑specific constraints and negotiate resource allocation with ExPs to reduce risk.
- Own marketplace evaluation efforts (RFI, RFP) to ensure Blue Rock’s ExP network is either aligned or leading industry standards for performance and efficiency.
- Maintain strong network awareness across all three categories (analytical QC, contract manufacturing, device development) to enable pivots when necessary and build network robustness.
- Process purchase requisitions, review open purchase orders, and follow up on status of placed orders as required.
- Support the annual budget process for all categories by aligning functional needs with ExP pricing and timing.
- Minimum of a Bachelor’s degree in business, scientific discipline or related field and 13+ years of experience in a similar role managing third‑party relationships and operating in a matrixed environment, or a Master’s degree and 11+ years.
- Highly functional in a fast‑paced dynamic company with ability to prioritize issues under differing pressures and shifting timelines.
- Demonstrated ability to be highly organized and proactive.
- Demonstrated ability to view change or problems as an opportunity to learn and grow; adjusts easily to change.
- Works well with others on both an individual level and in team environment.
- Excellent written and verbal communication skills; ability to clearly communicate complex challenges and solutions internally and externally.
- Experience with GxP guidelines/documentation and general GMP experience.
- Experience in working with electronic systems such as ERP, Smartsheet, Oracle, Coupa, Microsoft Office programs.
- Ability to analyze and resolve abstract problems independently.
$145,000 - $171,500
Equal Opportunity WorkplaceAt Blue Rock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability‑related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
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