Proclinical is happy to announce that we are advertising an opportunity for a talented and hardworking individual to join in a Senior Manager, Regional Business Quality position at a healthcare company that specialises in accelerating breakthrough innovations and providing essential technology. This company, that provides an innovative range of diagnostic solutions and medicines, is looking for a hard-working individual to join their German team in Frankfurt.
The Senior Manager, Regional Business Quality will promote correct standards of quality within their designated region by influencing and managing all quality related activities. They will work closely with the Director, Business & CLS Quality to develop and implement Quality strategy, whilst providing leadership to their region. They will interact with, and provide oversight to, local operating companies to ensure adherence to QMS, whilst serving as the EU Authorised Representative for compliance with EU MDR.
Job Responsibilities:
- Promoting correct standards of quality within their designated region.
- Influencing and managing all quality related activities within their region.
- Working closely with the Director, Business and CLS Quality to develop and implement Quality strategy, whilst providing leadership to their region.
- Interacting with, and providing oversight to, local operating companies to ensure adherence to QMS.
- Serving as the EU Authorised Representative for compliance with EU MDR.
- Building strong relationships with key business partners, and collaborating with them to meet quality objectives.
- Supporting the implementation and maintenance of local processes that describe the creation and management of local procedural documents in line with global and local regulatory requirements.
Skills and Requirements:
- A Bachelors' degree in a Scientific or Engineering subject or related field.
- An advanced degree, such as an MS or MBA, is preferred.
- A minimum of 10+ years of demonstrable experience in a medical device field.
- 5 years of experience in a LOC/Affiliate/Business Quality role at a manager level preferred.
- Professional certifications, including Quality Auditor, Quality Engineer, Quality Improvement Associate, and Six Sigma, would be preferred.
- Must be, or have the ability to be, an EU authorised representative, and as such, be able to assist with Incident and Field Safety Corrective Action (FSCA), reporting in cooperation you and your distributors.
- Demonstrable experience within a global organisation in a quality leadership role, including leading cross-site and multifunctional organisations.
- Demonstrable experience with stakeholder management, and the ability to effectively collaborate across a global organisation.
- Demonstrable experience with Health Authority Inspections and audits (e.g., MHRA).
- Demonstrable knowledge of quality systems and other standards, including ISO 13485, ISO 9001, FDA QSR, etc.
- Strong knowledge of good manufacturing practices and good documentation practices.
- Demonstrable experience with handling product recalls, complaints, and field action investigations.
- Strong experience with local re-labelling and repackaging, local supplier quality, distribution and warehouse quality.
- Expertise in CAPA activities regarding complains, recalls, and other related non-conformances.
- Strong experience in providing Quality strategies for product registrations and product flow.
- A customer focused approach, with highly effective teamwork and collaborative skills.
- Highly personable personality.
- Detail oriented with the ability to work independently and manage competing priorities.
- Planning, organisational, and time management skills.
- Professional interpersonal skills, excellent oral/written communication, and influencing skills.
- An ability to work effectively in an international, multicultural, matrix organisation.
- An ability to work well between functions, and across all levels of the business and effective time management skills are essential.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Josh Godden on + 442038540101 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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