Posted on about 2 years ago by Gerry Kennedy
Quality, Senior Manager
Over the past five years our client has enjoyed double digit global growth though a judicious strategy of acquisitions and sales growth. This highly regarded pharmaceutical company is now looking to hire a bright, action-oriented self-starter to take on the challenge of delivering on its highly ambitious future plans.
Reporting to the Associate Director of Quality, the Senior Manager is responsible for supporting quality operational activities for specific product portfolios within an assigned business unit. They will support the representation, communication and management of quality issues with internal partners, (including but not limited to business unit, technical operations, supply chain and R&D) and external partners (including but not limited to CMOs and 3rd party laboratories). The successful candidate will also support and execute quality operational, strategic and team goals for their product portfolio and personnel in order to assure the highest quality standards and regulatory compliance.
The Senior Manager is a team member on a quality operational team responsible for the quality operational activities for specific product portfolios within an assigned business unit. They are responsible for ensuring the highest quality standards for the product portfolios by managing the operational quality system elements of deviations, CAPAs, change controls and product complaints.
This team member is further responsible for ensuring the highest quality standards for the product portfolios by the tracking and monitoring of batch, stability and quality control data. This team member supports and serves as the analytical, technical and quality operational expert on the product portfolios within the assigned business unit.
- Lead quality for product portfolio to internal partners.
- Lead QA oversight at CMOs and 3rd Party Labs.
- Drive and execution of in-process monitoring, investigations, change controls, CAPAs, and process validation.
- Lead and communicate risks to product, supply, patients, or business, propose solutions, escalate and communicate in an appropriate and timely manner.
- Execution and support of vendor audits.
- Preparation of materials for business reviews and routine operational meetings.
- Preparation for business unit Monthly Business Reviews.
- Assurance of safety, identity, purity of product(s) within each business unit.
- Oversight of all product testing, methods, and investigations.
- Assurance of method adherence, expertise and validation.
- Execution of product complaint handling, manufacturing investigations, tracking and corrective actions.
- Monitoring, tracking and reporting Quality KPIs.
- Tracking and monitoring of quality control data.
- Tracking and monitoring of batch trending data.
- BA/BS in Chemistry, Biology, or equivalent required.
- 5+ years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing.
- Expertise in pharmaceutical product quality.
- Ability to work with high level contact and exposure to sensitive information necessitating considerable use of discretion and judgment.
- Ability to partner effectively with internal and external partners.
This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills. We value and look to recruit people with the following approach to work.
• Action Oriented
• Problem Solving
• Strong Technical skills
• Priority Setting
• Drive for Results
• Strategic Agility
• Deals with Ambiguity
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