Associate Director QA (GMP/GDP), Pharmaceutical R&D, Surrey
Quality Assurance, GMP, Qualified Person
Permanent Position, Excellent Conditions
Introduction
Our client stands at the leading edge of science and technology and has an R&D strategy^focused on Urology, Diabetes & Metabolism, Renal Medicine, Cardiovascular Disease and Pain. With a healthy and challenging pipeline and over 30 major ongoing projects in late Phase development, the employees here have unrivalled access to personal growth and recognition
Working for this leading Pharmaceutical Company you will be allowed to innovate, accelerate research using your own intuition and enable patient benefit whether it is in clinical trials or managing product lifecycle. Do not^hesitate to consider these openings, they offer security, autonomy and significant career opportunity.
Company growth has resulted in two new headcount openings both to be situated at the company's European office close to the M25 near Heathrow.
CSL is retained to identify suitable candidates for two new roles as follows:
1. Associate Director, Quality Assurance (This role requires QP eligibility)
2. Senior Manager Quality Assurance (GMP/GDP)
Both roles oversee the Quality Assurance aspects of our client's products in terms of GMP and GDP at European manufacturing sites, 3rd party manufacturing sites and commercial sales and marketing affiliates. We are therefore looking for applicants with QA experience within Pharmaceuticals in^international settings. The position has no direct reports. These roles require considerable influencing skills, and the hiring manager is seeking robust, articulate individuals who have the cultural sensitivity to know how to solve difficult manufacturing issues across many cultures.
These senior roles involve audit and visits to affiliates the applicants must be willing to travel regularly. Employment conditions are excellent. The company offers a relocation package for eligible candidates.
Job Summary - Associate Director (QP scope)
To realise high quality consistency of products in both development and commercial stages.
To monitor the quality risk for QA of European Marketed Products in terms of GMP and GDP
Lead and supervise QA of such Products including Development Products, based on Quality Systems of the sites and departments.
Products include Active Pharmaceutical Ingredients (API), Investigational Medicinal Products (IMP) and Authorized Medicinal Products.
To^coordinate and cooperate QA Activities with European manufacturing sites, CMM-QA and EU Region Affiliates communicating with HQ QA of API and other regional QA.
To develop relationships with our clients stakeholders EU-QA, DSP/PV, Legal, Operations,^Regulatory and Affiliates.
To collect new developments in external Quality Assurance requirements, EMEA, ICH etc. and give the training to relevant departments.
Auditors below this level of experience will be considered for the Senior Manager opening, duties mirror this but work will be supervised as the incumbent diversifies experience across product lifecycle.
These roles have been advertised before, and previous applicants will not be reconsidered.
Essential Skills & Qualification
Candidates are likely to have been operating at Manager/Senior Manager level within an EU R&D setting to be considered for the AD level appointment.
Pharmacy or Chemistry qualification desirable.
Candidates who have not audited CMOs are unlikely to be considered. We will only screen those with breadth of skill in the first instance so do not be disappointed if you do not secure prompt, feedback.
Quality Assurance and Quality Control experience as a pharmacist or equivalent qualification in European Pharmaceutical Manufacturing environment is essential.
Eligibility for Qualified Person (GMP) or experience as a QP
CMO and site auditing experience.
Knowledge of GMP and QA systems.
Knowledge of European Directives related to Pharmaceutical Industry.
Multi regional experience essential
Supplementary Requirements:
Software Competence: MS Office,
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes US, Japan and EU
Flexible^Working Hours: Yes
Employer: Pharmaceutical R&D Company
Employment Type: Permanent
Hours: Full time
Location: UK; Office Based access near e.g. M4/M25
Employer Benefits: Company Pension, Car Allowance, Life Insurance, Private Healthcare, Bonus, Childcare Vouchers. Relocation Assistance.
Keywords: Director, senior manager, AD, quality, Pharmaceutical, R&D, MS Office, QA, API, IMP, MP, Quality Assurance, Audit, Inspection, CAPA, Findings, CQA, GMP, GDP, GCP, Qualified Person, QP, Auditor, Inspection, CMO, European.
Assigned Consultant: Avril Horn at CSL Recruitment on 01932 234 686
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only re