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Job Details

Director of Quality

Company: Clinical Professionals Ltd
Location: East Anglia
Reference: J32082
Closing Date: 05 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: Depending on experience

Job Summary:

An exciting opportunity to join an expanding Pre-Clinical Bio-Pharma organisation who are recruiting a Director of Quality to have responsibility of defining a Quality Management System to encompass all relevant company activities.

Requirements:

Director of Quality
Location: East Anglia
Salary: Dependent on experience
Duration: Permanent

An exciting opportunity to join an expanding Pre-Clinical Bio-Pharma organisation who are recruiting a Director of Quality to have responsibility of defining a Quality Management System to encompass all relevant company activities, provide advice and support to companies development teams with regards to management of quality issues and ensure contracted organisations supporting the company GXP activities are selected and responsibilities are defined and documented. You will also work closely with the VP of Quality to monitor the performance of GXP service providers with regards to quality standards required to support the organisations activities.

Responsibilities (to include, but not limited to):
* Maintain awareness of, and ensure compliance with company policies and procedures relating to quality standards within the company.
* Ensure that the QMS meets all necessary regulatory requirements, including good practice guidelines and standards, with specific emphasis on GCP Compliance.
* Work with the VP of Quality and development teams to implement the QMS as an enabler for the delivery of company programmes.
* Ensure that quality issues do not compromise or impede progress of the business' programmes.
* Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.
* Implement defined quality standards and metrics to monitor compliance.
* Ensure external contracted organisations supporting the business' GXP activities are selected and responsibilities are outlined, defined and documented according to company procedures.

Experience required:
* Proven track record of monitoring and influencing the quality performance of contracted service providers, including external audit experience.
* Comprehensive knowledge of GCP Requirements for biologics.
* Proven track record of monitoring and influencing internal client group quality compliance, including self-inspection audits.
* Basic understanding of GLP and GMP requirements for biologics.
* Experience in the design and management of a quality system.
* Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharma companies.
* Substantial experience of managing quality issues in a biotechnology or biopharma setting.
* In-depth knowledge of GCP and related industry/regulatory guidelines governing clinical trials in the UK, EU and USA.
* Excellent communication skills.
* Excellent negotiation and influencing skills.
* Highly developed conflict resolution abilities.
* Conversant with quality requirements of EU Directives and ICH biologics guidelines.
* Knowledge of cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU and US.

If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion.
Please note, you must be eligible to work in the UK.

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Apply for this job: Director of Quality

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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