Head of Quality, Consumer Healthcare / Medical Devices, FMCG

Job content

Head of Quality

Location: Hull, UK

New Mandate: As a preferred Global Headhunting supplier to the world’s leading Consumer Health and Hygiene FMCG Powerhouse we are proud to work on another outstanding opportunity. You will work with the best people to challenge conventional thinking and to keep giving customers innovative solutions for Healthier Lives and Happier Homes in these unprecedented times.

We want to talk with experiencedSenior Quality Professionals with Passion, Potential and Ambition to take up this new role in a growing Global Qualityteam, reporting directly to the Global Quality Director - Health

NB we are also working on a number of other key opportunities for Certified Qualified Persons at the flagship Hull facility, including Quality Compliance Manager, Release for Sale Manager, and roles for Newly Qualified QPs - please get in touch to discuss

Do you have:

• Life science degree
• Certified Qualified Person status and/or the credibility to manage other QPs
• Broad understanding of manufacturing operations business and quality management systems
• Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical & Medical Device products predominantly in Europe and the USA, however development of global regulatory requirements will be expected.
• Proven track record leading in a manufacturing environment.
• QA systems audit experience.

Summary responsibilities:

• To provide strong and inspirational leadership to the Site Quality organisation.
• To represent Quality on the Site leadership team, escalating risks and guiding and partnering in solutions.
• To ensure the ongoing compliance of regulated operations, providing expert support and clear, pragmatic advice to the Site.
• Balancing compliance with efficiency; ensuring resources are focussed commensurately with levels of risk.
• To ensure the quality management system is business-appropriate and compliant and executed efficiently and effectively.
• To set the direction and strategy for the Site Quality team; ensuring continuous compliance performance improvement and proactive identification of compliance risks and resolutions.

Scope of role:

• Ensuring factory activities are fully compliant with regulatory and guidelines to minimise risk to consumers, company and brand name.
• Ensure that any risks to new and existing product developments are identified and communicated prior to introduction to the factories at minimum risk of non-compliance, rejection at time of manufacture or subsequent failure in market.
• Facilitate the identification, communication and the ongoing removal of identified quality and compliance risks. Communication to Global Supply Quality directorate, Site Director, R&D, SSG and other key function heads as appropriate.
• Management of external regulatory and third-party customer audits received by the factory.
• Provide QA/QC advisory / guidance to Co-packers and licences supplied world-wide.
• Strong links to Commercial Quality, Regulatory, R&D and Planning Departments
• Is a member of the Site leadership team

Accountabilities:

• Responsible for all Quality activities on site.
• Manufactured products meet cGMP requirements.
• Ensure Quality strategy develops continuous improvement culture in reducing non-compliance that may prevent routine release or regulatory inspection compliance issues
• Ensure quality system documentation exists for all processes and products.
• Regulatory audits hosted.
• To decide on release or rejection based on Compliance or otherwise with specification.
• Responsible for delivering to Quality budget
• Developing staff capabilities, both behaviourally and technically to ensure the ongoing requirements of the business are met, suitable succession plans are in place and staff are given an opportunity to grow and develop.

Personal Attributes:

• Good communication skills and able to debate and negotiate with personnel from all supply functions personnel
• Demonstrated people management skills
• Well-developed influencing and problem solving skills
• Diplomatic and tactful in difficult situations
• Highly motivated and confident. Organised and able to deliver concise written or oral summaries to senior management
• Able to lead on improvement plans within factory, identify and introduce new technology, requires a good manufacturing knowledge and an understanding of factory/quality management system.
• Able to train and coach others in risk assessment and auditing techniques
• Persistent and driven to achieve a final solution. A completer finisher.

Success will be very visible and well rewarded in an elite International team. You should be a self-starter, with great influencing and communication skills, and the drive to work with authority and autonomy.

We want to help you to realise your ambitions and reach your fullest potential.

Please contact Duncan with your CV today by applying

Whether for this immediate role, or for further along your career, it will be great to get to know each other in strictest confidence of course.

Thank You, Duncan

duncan@hedgeimpact.com

We are focussed on making positive social, economic and environmental impact, across industries.

We and our clients champion diversity and inclusion. We are stronger and happier because of this and it’s the right thing to do. It is our responsibility and privilege to help talented, value-driven people thrive. Talent is evenly distributed throughout the world. Opportunity is not yet - and we are working to be part of the solution. We are welcoming, respectful and supportive in all that we do and in our community.

Notes on COVID-19

· While restrictions apply, we replace all of our usual face to face candidate meetings and screening interviews with video calls/meetings or phone calls.

· All client/candidate interviews will also be completed remotely, including case study and panel discussions

· No one will be asked to travel unnecessarily, take risks or contravene any official advice or instructions, and no one will be put at any disadvantage in these processes due to the restrictions

· Protocol for on-boarding will be defined within advice at that time

· We remain available on the usual contacts throughout

· Please refer to www.hedgeimpact.com/covid-19/