Featured Advertisers
This job has been removed from the site. Here are the details which were advertised. |
View Similar Jobs View other jobs from this advertiser |
VICE PRESIDENT, QUALITY
Company:RFT GROUP |
||||
Job Reference Number |
14565674 |
Client ID: |
RI/ |
|
Posted On: |
Feb 5 2012 |
|||
Location: |
DUBLIN |
|||
Job Type: |
Permanent |
|||
Salary: |
EXECUTIVE PACKAGE |
|||
Benefits: |
|
|||
Our client is a highly successful, fast expanding pharmaceutical company focussed on US speciality markets. Continued rapid growth has led to the need for a newly created senior executive role : Vice President, Quality
Job Spec :
Responsible for the quality units in both Dublin and the USA, ( others as they come on line). The quality unit consists of Quality Control, and Quality Assurance. Responsible for the commercial Quality unit in the US which includes release of a number of key products.
Member of the company Management Team and gives input into business strategy.
Chair of the Quality Leadership Team which looks at GCP and GMP systems.
Member of IT Security Committee and other adhoc corporate groups.
Liaise with Corporate Compliance Officer
Key Internal contacts :
Function Heads - Determine overall business needs
- Ensure compliance of sites to internal and regulatory guidelines
- Ensure the organisation understands the product risk associated with compliance and quality and minimising such risk
- Ensure the best quality standards are applied to company products
- Develop products so that they are robust, compliant and without significant delays in the approval process.
- Facilitate compliance in conjunction with the Chief Compliance Officer.
Key External contacts
- Corporate customers and strategic partners in the pharmaceutical industry
- External bodies and regulatory authorities as appropriate
Key Accountabilities
· Design and implement best practice quality improvement programmes for the sites.
· Direct and manage senior Quality staff to implement quality programmes and control raw material receipt, work in progress and finished product release in line with best practice and regulatory requirements.
· Ensure that appropriate quality KPIs are reported from the sites.
· Ensure that the sites are effective in the management of Quality Laboratories, Quality Assurance and Compliance functions while providing support and direction to those charged with the management of same.
· Ensure that the site quality group have a good business model but are also correctly resourced for headcount.
· Develop quality polices for the sites and ensure adherence to policies and corporate procedures through internal audits.
· Maintain quality and regulatory compliance at the sites and ensure there are no significant regulatory agency citations.
· Ensure that product quality reviews are completed such as annual report and annual product reviews.
· Authorise significant changes to the product manufacturing and supply chain process.
· Liaise with US and EU agencies on GMP and GCP quality issues such as FDA, EMA, DEA.
· Maintain the Quality systems in any contracted aseptic manufacturing sites.
· Ensure the site CAPA systems are in place and atypical trends reported.
· Develop the Quality group through the initiation of programmes which include projects designed to improve overall product quality.
· Pursue qualification and validation programmes through the establishment of appropriate protocols.
· Ensure that GMP, GCP and quality audits of the sites and facilities are conducted on a routine basis and those corrective actions are closely managed and implemented. Allow audit resources available to CCO from time to time.
· Ensure awareness with new developments in quality practice and promote same across the site.
· Total quality budget over $TBD dollars.
· Have three or more direct reports and 20 or more global reports.
· Travel to company sites, clients and partners on frequent basis.
· Develop and roll out automated GMP systems such as Electronic documentation management systems to the sites. Ensure overall qualification of IT systems if GMP applies.
Person Spec :
Preferred candidates will be educated to Masters or PhD level in a science discipline while having an excellent understanding of quality protocols. Qualified person status desirable.
Strong understanding of, and experience in quality management
15+ years’ experience gained within a high volume, finished product
pharmaceutical manufacturing
Environment. Excellent understanding of quality/regulatory principles as
they apply to the industry
Proven track record in people management and development
Logical and problem solving skills
High level of customer orientation/understanding
Strong interpersonal skills
Strong communicative skills
CV to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie
