Quality Control (QC) Manager

• 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.

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.