Title: Senior Manufacturing Manager
Location: Dun Laoghaire
Member of a Work Cell within the Operations team to support the external Supply Network of the company.
- Support the Site Operations Manager in all aspects of the business to ensure on time delivery of all key products and projects, with key focus and ownership of Quality records including Deviation records, CAPA, CAPA EV, and Change Control records.
- Active participation in Work Centre Team meetings with the contract site as well as internal site team, working collaboratively with the four pillars of Supply Chain, Quality, Operations and Process Development.
- Project Management and Technology transfers when necessary: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
- Site performance monitoring: Report contract site performance metrics to site lead.
Identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), along with oversight and reporting of procurement/payment of invoices,
- Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
Qualifications and Experience:
* Bachelor's in Business Administration, Engineering or Science-related field
* 5+ years of experience in DS, DP or packaging manufacturing environment, with preference for Pharma or Biopharma manufacturing (Drug Product) experience.
* 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
* 2+ years of project management experience leading multi-functional and/or multi-location team
* 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
* Demonstrated matrix management and influencing skills.
* Manufacturing and cGMP knowledge / experience.
* Demonstrated negotiation skills.
* Operational Excellence proficiency and ability to drive continuous improvement.
* Financial/budgeting knowledge and business acumen.
* Proficient project management skills.
* Problem-solving and critical thinking.
* Understanding of contractual requirements.
* Technical writing and multi-level communication skills.
* Demonstrated ability to lead effectively in collaborative/team environment.
* Demonstrated ability to take initiative, drive action, and work under minimum supervision.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.