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Quality Manager (CMO)

Major Duties and Responsibilities

• Onboarding of new CMOs

• In selection process ensure quality knowledge awareness of CMOs in the industry and their suitability for Rosemont use and business development projects. As Quality representative has the necessary quality experience to understand quality aspects to be delivered.

• Coordinates the writing of RFPs with the relevant Rosemont departments for new products suitable for CMO & CDMO manufacture that are not for technical transfer into Rosemont Leeds .

• Responsible for distributing RFP to suitable CMO, liaising with the Business Development team, and coordinates RMT SME team in review and approval of CMO, managing communications between the two parties.

• Conducts CMO audits liaising with the Rosemont Supplier Relations team to ensure all audits are recorded in the Rosemont Audit Process prior to first GMP activity at the CMO.

• Coordinates with the Rosemont PMO team for CMO Setup and product transfer ensuring knowledge management is maintained at Rosemont.

• Adherence to Specifications and Standards

• Act as the quality liaison between the CMO and Rosemont departments ensuring the CMO attains and meets the quality standards expected by Rosemont and in accordance with cGMP.

• Assure that products manufactured by CMs and CDCMs abide to specifications and Industry standards.

• Maintain consistent quality and minimise defects.

• Strive for continuous improvement of product and processes.

• Identify areas for enhancement and implement quality- enhancing measures.

• Quality events

• Clearly define responsibilities related to investigates, corrective and preventive actions (CAPA), and other quality- related processes.

• Raises Rosemont QMS to document CMO changes and deviations ensuring CMO deviations and quality events are addressed promptly.

• Quality Management of Commercial CMOs

• Conducts status meetings at an agreed frequency with CMOs to ensure quality standards are maintained against agreed KPIs and minutes all discussions and actions. Acts as the Rosemont Quality representative at all times .

• Coordinates on quality matters with Rosemont departments in delivering CMO needs to an agreed timeline e.g. Supply and inventory issues, Quality Documentation and Change Management and Regulatory and dossier updates.

• Lead Auditor who conducts CMO audits liaising with the Rosemont Supplier Relations team. Ensures issues are resolved in a timely manner providing support to the RMT CMO Planner/Supply Chain in relation to Quality issues impacting supply issues.

• Ensures that CMOs are audited through QA and is the Lead Auditor for CMOs.

• Team Leadership – CMO Manager having no direct reports requires the necessary leadership skills to manage and lead the CMO needs with the relevant departments at Rosemont ensuring Rosemont delivers to the agreed timelines so that the CMO is not adversely affected.

• Lead, motivate and coach the project and CMO eam to be at their best. Engage and enable each team member to ensure they can optimise their contribution to the company.

• Build team and cross-functional team climate, levels of collaboration and engagement.

• Help build Rosemont’s EVP to ensure we remain a great place to work and grow careers.

• Develop and build the capabilities and capacity of the team to ensure it is high performing and future ready.

• Recognise and celebrate individual and team success.

Financial Management & Budget Oversight:

• In collaboration with functional heads, manage assigned budget, ensuring financial objectives are met while optimising resource utilisation and maintaining cost-effectiveness and efficiencies.

• Operate within agreed budget constraints.

• Governance & Compliance

• Ensure all procedural and governance standards are met regarding compliance, competition law, anti-bribery law, criminal finances act, GDPR and industry codes of practice.

• Supplier management and governance.

• Ensure adherence to Group LOA, within area of responsibility.

• Thought Leadership

• Stay abreast of the latest development and trends relating to area of responsibility. Share best practice and insight to drive performance and increase efficiencies.

• Provide management information and insight to inform management decision making for areas of responsibilities.

 Competencies

• Strong results focus and tenacity to overcome challenges and build opportunity.

• Highly analytical with attention to detail.

• Ability to meet deadlines and work in a high growth, fast paced, dynamic environment.

• Ability to work as part of a team.

• Experienced Leadership skills

• Problem/situation analysis.

• Oral and written communication skills.

• Ability to build collaborative relationships.

• Analytical and detail thinking skills.

• Good judgement making skills.

• Ability to develop and mentor others.

• Decision-making skills.

• Problem/situation analysis.

• Strategic thinking skills

Knowledge and Experience

Minimum Expected Education

-Min Degree educated or equivalent –master’s or professional qualification Chemistry preferred.

– Ideally the candidate will be an Responsible Person (Import)/Responsible Person or suitable for attaining this level to be placed on the Rosemont Licences and conduct batch release for UK products where Rosemont is the MAH.

• Typical Years of Experience

– Typically a minimum of 6 years in the field and 10+ years in a Quality role 7+ years.

– Experience of working in a Private Equity environment is extremely desirable.

-Has broad pharma knowledge understanding the aspects of manufacturing, quality and project management and commercial understanding and the political savvy in dealing with third parties.

-As Quality representative has the necessary quality experience to understand quality aspects to be delivered

– Ideally the candidate will be an Responsible Person (Import)/Responsible Person or suitable for attaining this level to be placed on the Rosemont Licences and conduct batch release for UK products where Rosemont is the MAH.

• Additional Information Technical Knowledge

-Understanding of pharmaceutical processes: Familiarity with drug development stages, process characterization, and analytical methods.

– GMP (Good Manufacturing Practices): Knowledge of regulatory requirements and quality standards for pharmaceutical manufacturing.

– Tech transfer: Understanding how to transfer processes from development to commercial production.

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