LOC QA Operations Manager

Job description

Details:

Find a career with purpose. Learn about an exciting new opportunity at GSK.
Why GSK?
GlaxoSmithKline (GSK) is a science-led, global healthcare company that researches and develops innovative products. GSK currently employ over 100,000 people globally and has offices in more than 115 countries. Group revenues for FY2015 were £24 billion.
Most importantly, we help patients and consumers do more, feel better and live longer. What could be better than that?
GSK's Consumer Healthcare Local Operating Company (LOC) Quality organisation plays a vital role in ensuring that quality products are manufactured and supplied to patients and consumers across the world. The LOC Quality organisation is part of the GSK Global Manufacturing and Supply organisation and employs over 200 Quality professionals across Europe, the Americas, Asia, Middle East and Africa, who support over 100 LOCs worldwide.
What our employees say about us:
“We operate at the front end of the supply chain, ensuring quality oversight of the manufacturing and supply operation to enable quality products to be provided to our consumers and patients, and offering a fantastic breadth of experience of quality in a commercial environment.”
“Quality is a relatively new function within the new GSK Consumer Healthcare business and offers a great opportunity for shaping the Quality culture within a commercial environment”.
Meet Teri, Head of GSK Consumer Healthcare Quality
https://www.youtube.com/watch?v=BB54isUBKOk

What we're looking for:
We are looking to attract a talented Quality Operations Manager, who also has Qualified Person status to work within the GSK Consumer Healthcare GB&I (Great Britain & Ireland) LOC. This role will work closely with other functions to ensure we have a secure supply of quality products which comply with internal and external requirements, and are supported by an effective and efficient quality system.
About this exciting role:
The position of Quality Operations Manager within the GB&I LOC is a key role for the management and oversight of all operational and product related transactional Quality activities within the LOC. As GSK Consumer Healthcare holds a manufacturer's importation authorisation licence for a number of products, the role holder will also need to be a Qualified Person as defined in EU Directive 2001/83/EC. Reporting directly to the LOC Quality Lead, GB&I/Northern Europe, the position will ensure the effective, efficient and compliant operation of the quality processes that have an impact on the quality of the product and regulatory compliance.
The role will require building strong partnerships with Supply Chain, Customer Service and Logistics and Third Parties (contract manufacturers, re-packers, warehouses etc) and is a key role for ensuring the LOC can deliver compliant product to its customers on time.
Job Purpose:
• Ensure LOC Quality processes and systems are in place for all activities carried out across the local business which support the decision regarding placing product on the market.
• Ensure these processes, and the decision to place product on market, are in compliance with the GSK Quality Management System, GMP, GDP and regulatory requirements.
• Conduct batch release and QP certification on imported medicinal products.
• Manage all quality operational activities within the LOC which have a direct impact on product quality and regulatory compliance.
• Ensure, as appropriate, effective planning, investigations, problem solving, risk assessments, decision making and corrective and preventive actions for any incidents or changes that have a potential impact on product quality or regulatory compliance.
Key responsibilities:
Ensure LOC Quality processes and systems are in place, in use and are effective related (but not limited) to:
• Develop, specify and approve processes and systems that have an impact on the quality of products in line with QMS and local regulatory requirements.
• Accountable for review and approval of Quality Agreements/Technical Terms of Supply and liaison with manufacturing sites to ensure compliance to local registered details.
• Ensuring Distribution Risk Assessments are in place to determine and implement the controls necessary to maintain product security and integrity through the distribution network.
• Liaison with Contractor Management Organisation (CMO) Quality for products that are manufactured by contractors to ensure compliance to local registered details.
• Ensure any Third Party Supplier providing GxP services to the LOC is audited by central audit functions, has a Quality Agreement in place and, where applicable, holds valid GDP/ GMP Licenses.
• Work closely with supply chain organization and other functions, ensuring any changes which have a GxP impact are approved by QA through the change control process.
• Ensure LOC processes and systems in place for all activities related to receipt, returned goods, warehousing and storage of all products (medicines, medical devices, cosmetics, nutritional products) are in compliance with GSK QMS.
• To lead batch assessment and release activities to ensure releases are carried out in a timely manner, and meet relevant regulatory standards.
• Ensure that all checks on incoming products are conducted and to release product to the local market.
• To be one of two Qualified Persons responsible for QP certification of imported products on behalf of GB&I.
• Investigate and resolve Quality-related issues, such as temperature excursions, arising from deliveries of finished products. Perform quality related transactions and quality data maintenance within the Enterprise Resource Planning (ERP) system.
• Oversight of processes for positive release and quarantine.
• Manage all matters pertaining to GxP, Regulatory and QMS compliance for repacking procedures to ensure timely QA pre-approval and subsequently timely QA batch release of repacked orders.
• Be part of, and lead local incident committee meetings as appropriate.
• Collaborate with self-inspection and audits to ensure that local operations are in full compliance with GSK QMS, GMP, GDP and regulatory requirements for all marketed products.
Please apply for this role using the online application system. The closing date for applications is Monday 23rd May 2016.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Desired profile

Basic qualifications:

• Quality experience within industry, and application of Quality Systems & Quality Operations
• Qualified Person (QP) status.
• Minimum of 1-2 years experience within the Pharmaceutical / Consumer Healthcare Industries, preferably in the capacity of a quality specialist or a manager.
• Knowledge of regulatory requirements pertaining to GMP/GDP.
• understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
• Knowledge on effective quality documentation systems
• Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player – works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Strong interpersonal and negotiation skills
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible thinking – able to challenge and see views from different perspectives
• Ability to self-motivate and be resilient and focused under pressure
• Able to work effectively in English
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

Preferred qualifications:

• Consumer healthcare industry experience within a global QA function.