Qa Manager

QA Manager

VQ Life Sciences are recruiting for a Permanent QA Manager based in Nottingham. This position is for someone with 5+ years of Quality Management experience within the Pharmaceutical industry.

Function Quality – Pharma Business Unit

Reporting to Head of Quality

Direct Reports Qualified Persons, QA Coaches, Compliance Team Leader, Validation Team, Site Systems Lead

Organisational context

The Quality Manager is an integral part of the Pharma production unit, responsible for the overall quality and compliance of the products and services. The role sets the quality agenda for the business unit and works collaboratively with the Head of Quality, business unit teams, other site teams, customers, authorities and inspection bodies. Responsible for driving continuous quality improvements and developing the business unit to be as self-sufficient as possible.

Key accountabilities

Quality

Performing role of Quality Controller as required to maintain company MHRA Manufacturing Licence
Define and Implement a Quality Strategy to ensure full compliance of the Pharma business unit, including ISO13485, Customer, Corporate and regulatory authority requirements in all markets where we sell.
Lead the Pharma VC and CRB and Pharma Management Review.
Providing expert quality support to the Pharma business; for defining and championing compliance to GMP, regulatory, customer, corporate and company expectations plus quality standards; developing and maintaining robust evaluation and investigation processes to ensure all issues are resolved; training applicable teams in the operation and application of GMP, GDP and QA techniques; for supporting the releasing of finished product on time in full and completion of factory paperwork right first time.
Ensure that both the company quality systems and facilities meet cGMP and regulatory, corporate and customer requirements.
Interpret and ensure compliance with current legislation and anticipate and plan for future legislative requirements that impacts the business
Lead the QA team to ensure that the Supplier Assurance programme (including external audits of suppliers) provides assurance that all materials, components and critical services are sourced from approved suppliers: that PQR are generated RFT to required timelines and opportunities for improvement identified: the PQS is maintained and governance is in place.
The collation, documenting, investigating, reporting and close out of all customer and consumer complaints relevant to company manufactured Pharma products. Ensure compliance with Company, Customer, Corporate and Regulatory authority requirements.
Customer, Certification body, Corporate and Regulatory audits are managed with no major or critical findings found.
Quality acceptance of NPI / NPD from Industrialisation / R&D to “business as usual” in the business unit.
Ensures first run approval and sign off from a quality perspective, and agreement of simple, clear quality standards.
Ensures archive storage areas and complete end to end quality archive management for the Pharma business unit to comply with Company, Customer, Corporate and Regulatory authority requirements.
Ensure, where necessary, appropriate mutually agreed Technical Agreements are in place and in-date for all Pharma business unit suppliers, customers and service providers.

Cost

Manage department budget

To reduce waste linked to non RFT production

To reduce waste due to batch failures

To reduce the cost of non-quality.

Deliver

Lead team of QP’s who release licensed medicines under the provision of Directive 2001/83/EC and provide QP support as required for factory issues, expert reports, product quality reviews and documentation to support license applications/variations and product release e.g. GMP declarations.

Lead team to ensure all Pharma business unit products are released within the agreed timelines and in full.

A “compliant” Pharma business unit.

People

Strategic relationships with customers, authorities and internal partners

Coach and support the business unit

Be a business leader

Annual Budget

Annual budget responsibility for the role holder

Staff Responsibility

Number and profile of staff supervised whether full time, part time, temps etc

Team of ~15 including:

QP’s, QA Coaches, QA Compliance Team Leader, QA Experts and QA Officers

Planning

This should describe the requirement for planning and organising within the job. Some points to include ‘to what extent does the job holder plan ahead, what are the timescales daily, monthly, 1 year, 3 year plan

Horizon scanning and planning for next 3-5 years linked to regulatory expectations

Identifying CI opportunities based on monthly trending and feedback

Decision Making

Include examples of decisions made independently or are involved with, the nature of the role in decisions e.g. formal sign off, recommending, advising etc

Recommending needs for any market action (e.g. Withdrawal, Recall)

Formal sign off – Batch release

Advising – Acceptable GMP for production

Key metrics by which the role is measured/held accountable for:

Include examples of meeting KPI’s that the role holder will be expected to achieve e.g.

Administrator, 5% annual saving on stationary budget

QMS governance

Customer, Regulatory, Certification body, Corporate and Self-Inspection audit compliance.

Products released to schedule.

Leading and lagging quality KPI’s as defined by customer, business unit, Head of Quality or corporate.

No overdue compiled actions or unconverted occurrences

E-learning for self and team up to date

Training for self and team >95%

Knowledge, skills and experience

Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
Eligible to perform the duties of a Quality Controller under the provision of Directive 2001/83/EC and Directive 2001/82/EC
Qualified as a Lead Auditor, with experience of Supplier / API auditing.
Minimum of 5 years of Quality Management experience in the Pharma Industry
Member of relevant professional body e.g. RSC, RPS.

If you have 5+ years of Quality Management experience in the pharmaceutical industry and your interest in this Permanent Quality Manager position based in Nottingham, please get in touch.

Reference: DO324

Job Features