Skip to main content

This job has expired

Senior Quality Manager and Qualified Person (UK)

Employer
Consilient Health
Location
London Richmond office and flexible remote working
Salary
£60,000 to £80,000 depends on experience
Start date
3 Nov 2021
Closing date
3 Dec 2021

View more

Discipline
Quality, Qualified Person
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

ROLE TITLE:

Senior Quality Manager and Qualified Person (UK)

REPORTS TO:          

Head of Quality Assurance

BUSINESS AREA:

Quality Assurance

 

ROLE PURPOSE:

Responsibility for the review and QP release of product imported for sale in the UK by Consilient Health. Management of the release process and associated reviewers.

Assurance of quality compliance of the Consilient Health business.

Quality Management System maintenance and review to comply with all aspects of the MIA and WDA licenses.

Maintenance and review of TQA’s with service and manufacturing partners.

Auditing of suppliers.

Line management of direct report.

 

ACCOUNTABILITIES:

1. Product batch release

  • QP review and release for product imported from outside of the UK to allow sale of product in the UK. Batch release to be in compliance with:
  • Article 51 of Directive 2001/83/EC, as amended.
  • Article 55 of Directive 2001/82/EC, as amended.
  • EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, Annex 16, as amended or equivalent regulation.
  • Falsified Medicines Directive (FMD) 2011/62/EU, as amended.
  • Management of warehouse service provider quality systems to support remote batch certification activities
  • Related performance indicators: 
    • Review of batch release paperwork (BMR / CofA / Temperature data etc.) remotely from the manufacturing and testing sites, to allow progress to QP release.
    • Identification and guidance on batch deviation reporting and resolution (as required).
    • Approval of product technical files inclusive of Product Quality Reviews, TSE/BSE and any additional material compliance statements (e.g. Melamine),
    • Oversight of stability program maintenance and reporting.
    • Assure supplier licences and certificates are valid, and supplier assurance through risk assessment or/and audit.
    • Support internal self-inspection program
    • Maintain a register of all released batches

2. Supplier / Customer compliance

  • Ensure Quality Assurance (QA) requirements are met at all times by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in Consilient Health GMP and WDA licences, in order to support Consilient Health business continuity.
  • Ensure Quality Assurance requirements are met for compliance of Consilient Health as the Manufacturing Authorisation Holder for products.
  • Related performance indicators:
    • Conduct audits of suppliers (where Consilient Health is the MAH) and contracted service providers, as per agreed schedule and internal procedure, with follow-up and closure of any observations.
    • Assurance that current copies (notarised translations where applicable) of supplier licences and certificates are valid.
    • Assure Technical Quality Agreement remain valid and accurate at all times
    • Approve supplier and service provider “bona fides” checks and document approvals
    • Approval of customers on the basis of satisfactory bona fides checks. (where applicable)

3. Quality System Maintenance & Management

  • Oversight of the management and maintenance of the Consilient Health Quality system (ensuring measures are in place to support good documentation practice and data integrity principles, and effective governance of all company SOPs)
  • Guidance to the business for the awareness of new and revision to existing quality directives within EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use.
  • Manage the QMS performance level to maintain compliance of the MIA systems.
  • Related performance indicators:  
    • Approval signature of current Site Master File and Quality Systems and review and approval of subsequent updates.
    • Overview and management of change controls, deviations and CAPAs for assurance of their closure and effectiveness review.
    • Oversight, review and approval of all quality related company SOPs to assure accordance with review periods and current practice.
    • Review / conduct self-audit and inspection in line with schedules
    • Ensure all GMP / GDP activities are performed in compliance to relevant guidelines.
    • Involvement in company Quality Operations Review meetings.

4. Employee training compliance

  • Oversight of employee training records and compliance of employee training with regulatory requirements, (including Controlled Drugs training).
  • Ensure that QP training and continuing professional development are maintained on a personal basis.
  • Related performance indicators:
    • Co-ordinate efficient and effective document distribution and collation for entry into the Quality system
    • Ensure accuracy and availability of company employee training records for review during inspection or upon request of line manager
    • Escalate any areas of non-compliance to Head of Quality of Assurance.
    • Personal attendance at Regulatory authority seminars, with systematic maintenance, improvement and broadening of knowledge and skills to ensure continuing competence as a professional.  
    • Promote GMP and GDP through training and guidance internally

5. Company compliance

  • Comply with relevant legal and compliance requirements, regulatory and ethical standards and Consilient Health SOPs. 
  • Related performance indicators:
    • Achievement of quality and regulatory compliance for all internal and external audits.
    • Compliance of company processes and systems to GMP / GDP guidelines at all times.
    • Fully compliant with all internal and external policies, SOPS and processes.

6. Line management

  • Responsible for line management of batch reviewer
  • KPI setting and reporting
  • Related performance indicators: 
    • Determine KPI’s for batch release
    • Monitor and regulate performance of KPI to be reported to Head of QA on monthly basis
    • Objective setting of batch review
    • Line management of direct report
    • Identify training and development needs of direct report

 

QUALIFICATIONS, EXPERIENCE & KNOWLEDGE REQUIREMENTS:

  • Qualified Person (with >3 years’ experience) as defined in Article 48 of Directive 2001/83/EC, as amended, and Article 52 of Directive 2001/82/EC. Specific knowledge is required for solid dose forms (tablets and soft gelatine capsules) and sterile products (injections).
  • Continuous Professional development to assure current product knowledge and knowledge of pharmaceutical regulation and regulators.
  • Extensive knowledge of Quality Management systems within a pharmaceutical background.
  • Bilingual, English and Spanish (preferable).
  • Good inter-personal and communication skills.
  • Ability to work under pressure and remotely to the site of product manufacture and testing.
  • Excellent attention to detail.
  • Ability to prioritise work.
  • Effective time management.

 

COMPETENCY REQUIREMENTS:

Making things happen to achieve results: Passionate about achieving goals and is relentless in desire for improvement.  Delivers solutions with speed and simplicity. Demonstrates energy and drive in delivering results. Is proactive in approach and efficient & effective. Focuses on the end goal and on personal development

Innovation: Challenges thinking to bring about improvements. Seeks to gain a deep understanding of a topic and generate new ideas and new ways of working. Is flexible and agile and delivers different and better solutions. Embraces change, learns from mistakes and take smart risks

Leading: Takes responsibility for self and actions, seeks out opportunities to lead the way in projects, teams and business priorities. Possesses the knowledge and experience needed and works hard to meet the goals of the business. Trusts others to deliver the best outcome.

Communicating with others: Strives to ensure communication is timely, relevant and tailored to the people they are working with. Shows and builds trust and shares with respect and empathy

Team Player: Champions working together to create a high performing team; ensures real collaboration and true involvement. Uses own strengths and the strengths of others to create and celebrate team success. Approaches working with all partners, internal and external, with positive intent

Open and Honest: Behaves ethically and compliantly in all aspects of work and demonstrates fairness and integrity in dealing with all people. Gives and accepts honest constructive feedback and speaks the truth

Seeing things from others points of view: Puts self in the shoes of others and is inclusive in approach. Sees the big picture and is curious about other’s views and listens to understand

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert