West Pharma Sr Mgr Quality 

United States, North Carolina 

255113105

Job Summary:

Assure compliance of the plant processes and product according to corporate policies and procedures, regulatory requirements, applicable standards, and specifications. As the ISO management representative at the plant level, ensure quality system is implemented and its integrity maintained.

Essential Duties and Responsibilities:

• Manage Quality Staff at site to assure knowledge, required Quality personnel training qualifications, and execution of site Quality System. Conduct performance reviews, recruit team, put in place training and development plans, address issues in a timely manner.
• Establishes the duties and responsibilities of Quality team, prepares concise job descriptions.
• Ensure fulfilment of Data Integrity rules & procedures applicable on site.
• Responsible for the preparation and execution of the GMP training on site.
• Matrix Manager for the Site Analytical lab on site.
• Represent Quality Function as needed on site cross–functional project teams and global initiatives.
• Review and approve all site procedures and operation instructions to ensure that these comply with West global ESOP, EWI and quality manual.
• Responsible for the Quality Management Review, ensure that it is completed according to the established schedule and actions identified are implemented accordingly.
• Establish and monitor site Quality Metrics evaluating the effectiveness of the local Quality System. Responsible for the quality data trending e.g., CAPA, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
• Responsible for the site Quality KPIs reporting, monitor the trending, identify opportunities to meet the KPI targets. Responsibility for the data gathering and reporting of Annual Product Reviews, as required.
• Drive continuous quality improvement projects at the site based on site data (COPQ, internal rejects, complaints and audit observations) and customer needs. Establish the sites quality plans and ensure that the plan is being followed.
• Drive compliance to global harmonization initiatives
• Assure execution of internal audit program and Shop Floor Audits to assess effectiveness of quality system implementation and monitoring of compliance status (including data integrity requirements as per West procedures).
• Assure proper use of change management associated with validated processes used by site, according to West Global procedures and Change Notification Policy. Responsibility for the approval of change controls, qualification of new equipment and/or validation of new processes.
• Review, approve and ensure CAPA is implemented according to the implementation plan and effectiveness check is completed.
• Support/ facilitate Quality information and discussions at customer meetings.
• Participate in customer review meetings as support or as the Quality lead for the meeting, depending on the customer and needs.
• Assist Corporate customer quality team with specification review: evaluate and respond to customer specifications as to the sites ability to meet the customer’s stated requirements.
• Adjust in process/final sampling plans and related accept/reject criteria to ensure compliance to specification. Final Batch release decision, including responsibility for the execution and final disposition of IPC and incoming testing as well as trending of this data.
• Provide Input for preparation and tracking of the budget assigned to local QA on site.
• Lead interface with Regulatory Agency representatives during site inspections.
• Other duties as assigned.

Education and Experience:

• Bachelor’s degree in science or related field, Chemistry, Biology, Engineering, etc.
• 8-10 years' experience in Quality Assurance and GMP industry

Knowledge, Skills and Abilities:

• Prefer experience with sterilization requirements and classified environments for production.
• Knowledge of GMP requirements.
• Customer facing experience.
• Project management experience
• Able to always comply with the company’s quality policy and adherence to the corporate Code of Conduct.
• Working familiarity with Project Management Tools and Quality Risk Management.

Travel Requirements:

• Minimum travel requirement

Physical & Mental Requirements:

• Position operates in a professional office environment. This role routinely uses standard office equipment. May need to stand or sit for extended periods of time.
• While performing the duties of this job, the employee is regularly required to speak and hear. The employee frequently is required to stand, sit, walk; and reach with hands and arms.
• Use written and oral communication skills.
• Read and interpret data, information, and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze, and solve problems.