Operational Quality Associate Director at GSK in Rockville, MD

Site Name: USA - Maryland - Rockville
Posted Date: Jan 13 2021

Key Responsibilities

• Manage team of Operational Quality professionals (24/7) to support production activities
• Responsible for Bulk Drug Substance (BDS) disposition to secondary sites as per current validated process and regulatory requirements
• Review and approve deviation reports, corrective actions, validation and qualifications protocols and technical documents to support GMP decisions and material disposition.
• Approve production and supporting functions change controls to maintain GMP status of the processes and facility.
• Review and approve SOPs, batch records, forms and all other GMP documentation to support day to day operations
• Serve as QA representative at product team meetings (PTM, CMC, POMM), participate in facility design teams and specific drug product development teams
• Chair critical incident management meetings and provide Operational Quality advice to senior management on incidents
• Host Internal and External Quality Inspections as SME in Operational Quality topics and general production processes
• Support Data Integrity and Human Performance efforts to reduce incidents and increase engagement with employees
• Support new products and improvement initiatives as the primary point of contact for Quality on projects
• Ensure that Quality risks in productions areas are understood and appropriately mitigate to support production schedules
• Actively support performance initiatives to support performance improvements in the BDS release area to achieve site service goals

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors Degree in Science/Biotechnology, Engineering or equivalent experience
• 8+ years in a GMP pharmaceutical environment - Biopharm preferred
• 2+ years supervisory experience preferred
• Experience managing deviations and changes to processes as author, reviewer or approver
• Experience in GMP inspection/audit as a host or SME for a production or Quality function
• Knowledge in Performance Improvements tools i.e. Six Sigma or equivalent
• Validation and Qualification experience as reviewer or approver
• Ability to interpret and apply GMP, ICH and other regulatory guidelines. Critically evaluate individual processes and projects, then synthesize their insights to arrive at a summary of overall organizational status

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Excellent organization skills - spearhead both the planning and implementation stages of multiple projects
• Effective oral and written communication skills - able to speak, actively listen, and write/present well to different levels of the organization
• 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.

Why GSK?

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, rigour 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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