Distribution Quality Assurance Manager
Norgine, United Kingdom
Job Description
Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for a Distribution Quality Assurance Manager to join Norgine. The person holding this position will report to Quality Director, Distribution amp; Supply and be a member of the Corporate Quality team.
The Distribution Quality Assurance Manager has operational responsibility for compliance with Good Distribution Practice and quality system across all distribution activity, including transportation from manufacturing entities through distribution across the network and activity in affiliate companies. As the role impacts the entire Norgine network, including partners, this is considered to be a leading global role.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
KEY RESPONSIBILITIES amp; ACCOUNTABILITIES
- Ensure generally on behalf of all Norgine legal entities that Norgine distribution and Wholesale Dealers licences are fully supported and compliant with GDP expectations set in EudraLex Vol 4 and in particular EUROPEAN COMMISSION (EC) Guidelines of 5 November 2013 on Good Distribution Practice (GDP) of medicinal products for human use, across the Norgine world.
- Act in a capacity and ensure resource is available on behalf of Norgine BV as Responsible Person (RP) on the Norgine BV (NBV) Wholesale Distribution licence, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.
- Ensure resource is available on behalf of SpePharm AG and Norgine AG as Responsible Person (RP) on the Wholesale Distribution licence
- As lead RP, interpret Distribution Quality Strategy to ensure Norgine standards are understood and applied at Affiliate and Distribution partner level.
- Act as the global lead to ensure that Norgine affiliate companies, distribution Partners and manufacturing sites have a clear understanding of Norgine expectations in GDP and have the capability to fulfil their legal obligations.
- Establish reporting and metrics that deliver a clear understanding of the levels of compliance through the distribution network, to responsible management. Identifying noncompliance and associated risks and risk reduction strategies with clearly communicated action plans.
- Lead the RP Forum, providing the platform for sharing knowledge, compliance issues, training and mentoring to local Affiliate RP’s.
- Act as lead in quality event management and investigations for business critical quality events. Review, evaluate, and contribute to investigation into OOS or major deviations that are identified and follow-up on corrective actions associated.
- Provide support to the Global Distribution and Commercial function ensuring that ongoing operations and projects are deployed in a compliant effective manner.
- Identify and report operation quality risk or business risk and agree on risk mitigation/ remediation plans with Global Distribution, Affiliate companies and contract providers. Ensure the risk is reported and managed in appropriate manner to minimise impact on patient supply or to the Business.
Requirements
- Scientific Degree is essential with a professional qualification
- Eligible to act as Responsible Person (RP) and/or Responsible Person Import (UK specific) on a Wholesale Dealers Authorisation.
- Extensive relevant pharmaceutical industry experience would be advantageous including manufacturing and distribution. Experienced in hosting successful regulatory inspections.
- In depth working knowledge of regulatory requirements impacting the pharmaceutical and medical device industries, in particular the pharmaceutical distribution environment with an extensive knowledge of GMP/GDP.
- Excellent influencing skills and ability to establish effective working relationships and manage difficult, potential conflict situations with personnel at Norgine or distribution partners.
- Excellent verbal and written communication skills ability to present effectively to groups, able to effectively n