9318 Technical Manager
The External Quality Technical Manager reports to the Team Manager in External Quality and is responsible for quality oversight of external Contract Manufacturing Organizations (CMOs) and work with cross functional teams to ensure quality needs are defined and met.
This includes developing a CMO oversight strategy, mitigating risks at a CMO, negotiating quality technical agreements, managing the business relationship, maintaining supply, and achieving business goals.
The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These individuals build and maintain the Company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Provide quality oversight of external commercial and clinical CMO’s for those products and services as licensed by the HPRA and FDA, as supervisory authority.
Provide technical quality leadership for commercial and clinical products in manufacturing of API, filling, and packaging.
Support to enhance quality with risk-based strategies for the CMO technical oversight, considering the product life cycle, technical complexity and CMO capabilities.
Assess risk level of CMO and provide Quality oversight.
Contribute to department goals/initiatives and manage mid-level/large cross-functional projects for the department.
Collaborate with key stakeholders in projects to establish global standards and policies where appropriate.
Influence the development of Quality objectives and long range goals and support strategy realization through leading department projects and initiatives.
Provide quality decision, direction, and leadership in assigned interdepartmental meetings.
Inform/escalate CMO related issues to cross-functional teams.
Perform technical review and approve External Quality SOP’s, WI’s, specifications, protocols, change controls and deviations, as applicable.
QA oversight for deviations with major scope and conduct Material Review Boards (MRB).
Support and provide quality mitigation plans for significant technical risks at CMOs.
Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.
Drive implementation of a science and risk-based Quality Culture throughout the External Quality. Develop and implement a quality system, in line with applicable regulatory requirements.
Develop and improve systems/processes to support commercial and clinical product for QA release and other activities.
Assist with regulatory inspections and regulatory requests for submissions/filings.
Other duties assigned.
The ideal candidate will have the following skills and knowledge:
CMO Oversight – Understand risk management and able to assess health of a CMO and work with multiple CMOs.
Experience with collaborating with CMOs to mitigate and improve control strategy for clinical and commercial products.
Decision Making/Problem Solving – Identifies problems and be able to lead and handle complex situations (e.g. major investigations).
Collect input from key stakeholders in making sound and effective decisions and ensure the solutions and approach are aligned within and across teams.
Be decisive and move to action in the absence of clear information. Be proactive in implementing process improvements.
Influence and Collaboration – Success in working in a matrixed organization and work with different time zones.
Demonstrates effective communication and interpersonal skills that brings cross functional teams together to reach a shared goal.
Possesses strong verbal and written communication skills and the ability to influence at all levels.
Agility – Ability to pivot quickly and recover constructively from setbacks, while continually learning and modifying approach.
Leadership – Ability to interact with and provide leaders with guidance and recommendations to assist with decision making.
Ability to facilitate meetings, influence stakeholders, and manage teams effectively in projects and goals.
Quality Systems/GMP/Regulations – Working knowledge of GMP Quality Systems and cGMP Regulations (e.g., deviations, change controls, lot release, annexes).
Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
Advanced degree preferred.
Minimum 10+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
CMO oversight and risk management.
Strong attention to detail, organization and communication skills.