**Director, Regional Quality Assurance - Global Biopharmaceutical Company - Switzerland**
Company: Advanced Clinical Recruitment Ltd
Closing Date: 28 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary & Package
A very well known and exciting Global Biopharmaceutical company is actively looking for a Director of Regional Quality Assurance to join the group, at their main location in Switzerland. This role will be reporting into VP level, and will have significant strategic responsibilities across Quality. The company can also offer a fantastic opportunity to progress your already successful Quality Career, and there will be many chances to develop new and existing skills.
The Director, Regional Quality Assurance (Affiliates) will be responsible for leading Affiliate Quality Managers in the implementation and execution of the Corporate Quality System at designated affiliate(s) within the company. The candidate will be the primary Quality contact in their designated region, and will have strong experience in GxP’s and quality systems, be a key business partner and contributing member of the Commercial leadership team and have the ability to function independently and in a matrix environment.
- In coordination with the VP of Corporate Quality, the other Regional Quality Directors, Quality Assurance and related peers within the Global Quality organization, the Director Regional Quality Assurance will work to lead the successfulroll out and on-going compliance to the company's global quality and compliance systems, and associated procedures and standards.
- Provide leadership and resource management support to Corporate Quality and Affiliates located within regional area.
- Ensure that company Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordancewith US, EMA, other global and local GXP guidelines.
- Ensure the company is kept fully informed of new or emerging GMP, GDP and regulatory changes in their region and assess impact of regulatory change on Corporate policies and procedures.
- Lead the review and implementation of Quality Improvement/remediation plans for their regional Affiliates identified through Quality audits
- Participate as a contributing member of the Regional Leadership Team to assure goals and priorities are supported within the Quality System.
- Provide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activities. Assure sites are in a state of inspection readiness and lead support during internal and external inspections/audits. Partner with R&D and PV as required for GVP audits and inspections.
- In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
- Monitor compliance to regulations and procedures and communicate CAPAs and action plans to CountryManagement and Corporate Quality
- Act as Quality liaison between the local operational groups and Corporate Quality for GMP/GXP/GDP functions and activities.
- Partner with local, regional and global operational groups to foster a proactive approach to compliance.
- 10-15 years+ of Quality Assurance / Compliance management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
- Strong leadership ability.
- Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GXP, particularly those related to product distribution as required
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
- Exceptional communication and interpersonal skills
- Ability to work globally in a matrix environment
- Ability to influence senior management, peers and other colleagues without direct reporting lines
- Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
- Ability to multi-task and prioritize work
- Strong organizational ability
- Demonstrable computer skill
- Ability to freely travel up to 30%, (domestic and international)
- Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferable
- Interpersonal Savvy
- Global Business Knowledge
- Cross Cultural Agility
- Organizational Agility & Comfort Around Senior Management
- Dealing With Ambiguity
- Priority Setting
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
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