Do you want to work for a leading partner within the pharmaceutical industry that is accredited by over 30 regulatory agencies world-wide and has had 30% growth in the past two years? Would you like the opportunity to work for an industry-leading quality team?
We are looking for an customer-centric, people orientated and innovative individual to join a company who is a international leader for drug development and delivery and has an industry leading quality team and management system. Due to growth and new equipment on site, the company is looking for an established Associate Director of Quality Operations and will be responsible for providing leadership and quality management support, in the area of Quality Operations. This individual will have responsibility for Microbiology and Chemistry Quality Control aspects related to finished product testing and incoming material release and Quality Assurance on the facility.
Reporting to the Quality Director, your role will include:
- Develop, implement and communicate a clear strategic vision for quality to maximise employee focus and develop a competitive advantage.
- Maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. The successful candidate will bring an expert-level understanding of quality principles and regulatory knowledge.
- Will have proven ability to maintain strong relationships with customers, regulatory organisations and other industry contacts. This will enable the incumbent to anticipate changes in the quality/ regulatory climate, and redesign processes accordingly. It is crucial that this individual quickly gain the credibility and respect of his/her team, customers, and the senior executives of other functional areas within the site and Company, particularly with operating leadership. This will require the ability to satisfy the twin needs of compliance and productivity.
- Drive forward EH & S implementation and compliance within the function, in compliance with local laws and company policies.
- Ensure Quality Control systems are compliant with corporate and site procedures as well as industry standards such as but not limited to testing, training and analytical equipment
- Manage the QA Officers who are embedded in the 24/7 operation.
- Author/compile monthly, quarterly and annual summaries and metrics for the function; present summary data to site management/customers on a regularly scheduled basis
- Participate in the site Management Review
- Facilitate Investigations and root cause analysis in the laboratory area
- Facilitate the Data Integrity Improvement Programme
- Function as a Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives
- Recommend process changes as a result of trends from investigations and data analysis
- Host and participate in Regulatory Inspections and customer audits as required
- Ensure the adherence to the standards of quality ruled by current cGMPs and the Company's Quality Policies and site Standard Operating Procedures
- Author/review and ensure currency of SOPs related to the area of responsibility.
Skills and Experience Required:
- Minimum BSc preferred in Chemistry, Pharmacy, or Biology with extensive experience in pharmaceutical operation
- Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability
- Must have spent significant time within QC Management
- Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment is preferred
- Experience in the development of innovative and action-oriented quality programs is critical
- Experience in international regulatory compliance is considered a plus
If interested, please submit your CV and cover letter highlighting your expertise in relation to the role. We will send you a confirmation of acknowledgement, please note feedback can take up to 2 weeks. If you have been selected for an interview the process will be divided into 3 stages.
This is a full-time permanent position, paying up a competitive salary & benefits package. You will be based in the company's UK site in South West of England. Full details will be provided on application. In addition to a generous basic salary, the company offers the following benefits package:
- Bonus - up to 10%
- Annual holidays
- Share options Scheme
- Private healthcare - Single cover with BUPA
- Childcare benefits