- Develops the strategy and clear operational plans for the department.
- Provides effective leadership, resource and support to ensure that products accepted by the facility and/or released have been manufactured and packaged in accordance with cGMP and applicable laws.
- Co-ordinates stability and market impact investigations and chairs Product Incident Review Committee (PIRC ) and Local Incident Review Committee (LIC) meetings.
- Proactively influences the Value Stream by interpreting regulatory policy, establishing processes and providing cGMP and compliance guidance.
- Provides leadership to the Operational Quality (OQ) department by acting as a coach and mentor to support and develop employees on the team through performance check-ins, 1:1’s, training and development, performance management, talent management and reward and recognition.
- Communicates effectively and establishes processes and procedures to ensure smooth communication within the department, within the function, across functions, across sites, and with relevant central teams.
- Ensures effective and efficient two-way communications between Site Leadership and function to ensure stakeholders are aware and can track the quality records and batch status, accordingly.
- Ensures department’s L1 audits are performed and supports L2, L3 and L4 audits. Coordinate and approve responses to audit observations in a timely manner.
- Approves GMP related documentation such as Deviations, CAPAs, Change Control, Validation, SOPs, Technical Reports. Approves any changes associated with these documents to ensure they meet the needed requirements.
- Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors Degree in a scientific discipline or equivalent experience.
- At least 10 years of professional experience which includes experience with batch document review and investigating deviations, and working in more than one Value Stream.
- At least 2 years of effectively leading and managing technical and professional teams and/or operating in a matrix organization.
- Experienced in handling regulatory interfaces such as inspections and fronting audits.
- Proven ability to effectively influence networks to secure buy in and support for plans and ideas.
- Demonstrated evidence of providing effective business solutions and plans.
- Ability to interpret and apply GMP, ICH and other regulatory guidelines across a wide variety of situations;
- Excellent organization skills; Effective oral and written communication skills;
- Strong presentation and facilitation skills;
- Sound leadership skills and the ability to work effectively in a cross-functional team environment;
- Ability to manage appropriate resources (personnel, projects, budget, etc…) toward accomplishment of department and corporate goals;
- Ability to handle multiple projects and interface with individuals from various departments at various levels;
- Ability to work in a fast-paced environment in a results oriented fashion.
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.