Are you energized by a manager role that is responsible for quality assurance oversight of biopharmaceutical drug substance and drug product manufacturing at external organizations? If so, this Manager of External Biopharm Quality Assurance role could be an ideal opportunity to explore.
As a Manager, External Biopharm QA, you will be responsible for the oversight of contract manufacturing organizations that supply GMP product for use in GSK human clinical studies. This role ensures the quality of the product and the GMP compliance of the processes during the clinical phase of manufacturing and during industrialization and scale-up of the accelerated assets to the registration for commercial launch and supply. This role collaborates with business partners and the Commercial External Quality organization to ensure a seamless transition.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Provide input into the development of strategy, policy, group objectives and processes in Quality Assurance and with business partners
- Assure products meet regulatory requirements and that they conform to regulatory submissions.
- Interact with regulators and/or industry experts to represent GSK interests
- Interpret and apply regulations/policies to unique and often complex issues.
- Manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
- Manage resource, priorities, schedules and/or projects to assure delivery of group objectives.
- Lead a project, program or team activities which may include GxP.
- Contribute to an environment that optimizes employee productivity and adds value.
- Develop group skill sets and knowledge base to meet the needs of a changing environment.
- Direct the activities of one or more direct reports and/or lead a matrix team or business process.
- Actively engage in risk management activities to identify effective risk management strategies including the escalation of risks and their solutions.
- Act as a coach, mentor or trainer to develop others.
- Represent the group as a business contact or on a quality governance forum/council.
- Proactively identify, communicate and monitor business/regulatory changes that could impact on quality or compliance across Pharma R&D.
- Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers.
- Communicate and interact at various levels internally and externally to GSK.
- Develop internal/external networks to communicate with key stakeholders.
- Engage with the business in strategic/operational decisions on behalf of the group.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors or greater in biological sciences, biochemistry, chemistry, pharmacy or related scientific discipline
- At least 5 years’ experience in the pharma and/or biopharma industry
- Quality experience in GMP compliance/quality context
- Oncology/Biologics/biopharma/large molecule experience
- Experience with bulk drug substance (BDS) manufacturing
- Experience leading a matrix team
If you have the following characteristics, it would be a plus:
- Experience with sterile processes and aseptic standards (secondary manufacturing)
- Understanding of analytical techniques and biopharmaceutical product testing methodology
- Good communication and negotiation skills
- Exposure to the registration process for breakthrough therapy and Real-Time Oncology Review
- Collaboration skills; experience in building relationships across an internal network as well as with third parties.
- Experience leading direct reports
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.