Site Name: USA - Maryland - Rockville
Posted Date: Feb 7 2020
- 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.
Why you? Basic Qualifications:
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.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
This is a job description to aide in the job posting, but does not include all job evaluation details.
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