Jan 25, 2011 5:28:51 PM
Quality and Validation
Brentford, Southeast England
Ware, Southeast England
Bachelor's Level Degree
BS/BA or advanced degree requirements and/or equivalency in education and experience.
Technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques, dosage forms and the applicable GSK requirements.
Prior experience with auditing, either external or internal groups
Travel is required within region (approx. 50%).
Closing date for applications: 7th Feb 2011
- Skills to identify operational and regulatory deficiencies and design quality systems improvements.
- Has knowledge of the "letter and spirit" of regulatory laws and directives, and liability for non-compliance as related to pharmaceutical manufacturing.
- Knowledge in cGMPs, regulatory guidelines, and ability to interpret regulations and guidance in a fast-paced environment
- Required to be skilled at problem solving, negotiating, planning and organizing, decision-making and written and oral communication
- Leadership skills handling complex projects
- Can set up and manage Quality Systems
- Ability to build relationships, motivate and influence GSK and non GSK personnel
- Required to stay current on all existing cGMP policies expressed in such documents as the federal register, USP, European, WHO policies, etc. The ESQM is expected to review proposed guidance documents, assess impact to External Supply, and offer comment prior to the final official guideline enforcement.
- Capable of working independently, taking overall accountability for the day to day operations of the 3rd party sites making senior management aware of any issues with high business impact and influencing high-level decision-making processes.
- Fluent English and local languages.
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
Please indicate within your cover letter if you are confirmed as displaced (or potentially displaced) and at risk of redundancy.
Recent site operational Quality responsibility
Job Purpose and Key Responsibilities:
The Pharma External Supply Quality organization is responsible for ensuring the products supplied from contract manufacturers meet GSK Quality requirements. This is performed by providing the necessary GSK Quality oversight and management of these contract manufacturers as it relates to Quality and or Regulatory matters. The External Supply Quality Manager (ESQM) is the single point of contact between GSK QA and the external entity whether it is a contract manufacturer or customer. This position is responsible for managing each contractor from a Quality Perspective and lead Quality agreement negotiations and agreement amendments to ensure GSK’s product quality is protected. It is also responsible for ensuring that an on-going working relationship with the key contacts at each of the assigned contract manufacturing sites is maintained. These include but are not limited to Quality, Regulatory, Business Development, Production, Site Management and others. Supply of these products must be performed in a manner to ensure compliance to cGMP and GSK requirements, thereby ensuring product availability to patients. This position ensures that each contractor maintains the expected levels of compliance and quality as they produce GSK products
- Performs day-to-day quality management of secondary contract manufacturing and packaging firms to ensure product supplied by contract manufacturers meet GSK quality standards. The ESQM is the highest ranking GSK QA representative called upon to monitor product release, approve deviations, batch records and change controls, and perform investigations; measures complaints, deviations, rejections, and key process parameters that will meet the objectives of the GSK QMS policies and guidelines. This is achieved by effective management across multiple cultural boundaries. The above will at times address appropriate rationale for the release of atypical batch occurrences which will be approved with the associated contractor investigations.
- Facilitates and approves annual product reviews, validation protocols, and annual reports at contractors.
- Acts as the GSK quality point of contact for assigned contract manufacturing and packaging firms.
- Develops and negotiates Quality agreement contracts with regional contractors. The ESQM is the final GSK signatory on the quality agreement typically sharing this responsibility with the senior level Quality management at the contract manufacturing site.
- Communicates on an ongoing basis with contract manufacturing and packaging firms to assure that potential quality issues are identified in order to assure a secure source of supply. This includes being accountable for ensuring successful delivery and implementation of Quality Policies and Quality Alerts.
Contractor cGMP Management
- Supports lead GMP auditors by participating in annual audits of assigned contract manufacturing (4-days each) and packaging (2-days each) firms. Performs audit observation follow-up for audits conducted at contract manufacturing and packaging firms. These audits protect GSK, our customers and shareholders from the negative consequences of unidentified or unmanaged quality and compliance risk when assessed against cGMPs, POL-GSK500, QMS and Corporate Product Standards. The ESQM is accountable for:
- Ensuring that senior management is appraised of the identified risks and that appropriate corrective action plan is implemented.
- Mobilizing teams/support to address potential threats to GSK product supply operations.
- Guiding, supporting, training and assessing contractor sites that are preparing for regulatory inspection or undergoing major change.
- Manages the audit and compliance support program for assigned GSK manufacturing, distribution and marketing companies
- Upon request, conduct contractor audits in the lead auditor capacity utilizing the skills gained in the GSK auditor certification program.
- Manage the CAPA completion process within the CARISMA 2 system.
Contractor Regulatory Management
- Supports contract manufacturing by providing guidance and ensuring compliance to cGMPs
- Facilitate the implementation and maintenance of GMP Quality Systems for contract manufacturers
- Perform due diligence activity as required by local business initiatives.
Contractor Product Transfers
- Maintain detailed knowledge of the global regulatory environment and manufacturing and supply process as listed below:
- be responsible for reporting all serious cGMP/Regulatory compliance issues
- ensure that contract manufacturing facilities and systems meet and maintain current regulatory requirements and expectations
- review and respond to contractor regarding regulatory inspections on all matters that involve activities related to GSK products. Assess impact of inspection and contractor responses to regulatory observations prior to submission to associated agency.
- Reviews and approves the critical documentation associated with the introduction of a new product at contractor locations for sterile (terminal and aseptic) and non-sterile operations, primary packaging and/or secondary packaging.
- Provides quality requirements for technical transfer projects, validation exercises, lab methods, stability protocols, SOP’s, internals specifications, master batch records and others as needed.
- Providing technical assessment and authorization for product introductions and packaging operations.
Closing date for applications is Friday, Feb. 4th
- Participate in GMS Quality Council processes identifying Quality related issues, inefficient processes and drive continuous improvement. Escalate issues as needed utilizing the GSK Corporate governance policies.
You may apply for this position online by selecting the Apply now button.
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Formed after the merger of GlaxoWellcome plc and SmithKline Beecham plc in 2000, GlaxoSmithKline plc (GSK) is a global pharmaceutical,...