GSK is currently looking for an Operational Quality Manager to join our team in Rockville, MD. OQ Manager will be responsible for Operational Quality's day to day activities at LSM/SSM site including batch record review and day to day Quality Operations. The OQ Manager will manage a team of Quality professionals accountable for batch record reviews confirmation of GMP operations in production and support groups i.e. laboratory and engineering. The job holder will be the main liaison with production management team and will participate in daily planning meetings, approve deviations to processes, to support LSM/SSM activities

Key Responsibilities:

• Manage team of Operational Quality professionals (24/7) to support production activities and shop floor presence
• Ensure Operational Quality schedules and activities support batch record review and batch disposition needs Review and approve deviation reports, corrective actions, to support GMP decisions and material disposition.
• Review and approve SOPs, batch records, forms and all other GMP documentation to support day to day operations
• With the Operational Quality Associate Director, the OQ Manager will serve as QA representative at product team meetings (PTM, CMC, POMM), participate in facility design teams and specific drug product development teams
• Support Data Integrity and Human Performance efforts to reduce incidents and increase engagement with employees
• 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.

Basic Qualifications:

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

• BS Degree
• 5 years in a GMP pharmaceutical environment

Preferred Qualifications:

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

• Biopharm experience preferred
• 2 years supervisory experience strongly preferred
• Experience managing deviations and changes to processes as author, reviewer, or approver
• Knowledge in Performance Improvements tools i.e. Six Sigma or equivalent
• 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
• 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.
• 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.
• Technical expertise - a firm understanding and application of process improvements, Biopharm technical elements and Quality Compliance requirements for the role.
• Organization skills
• Leadership skills - coach and company game-changer, inspiring other team members to give their best effort and setting the direction for improvement initiatives

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