This position is accountable to ensure that site quality and compliance procedures and practices are compliant with standards and applicable regulatory and customer specifications and requirements.
The following functions report to this position: Quality Assurance, Quality Control, Quality Systems & Compliance and Quality Engineering.
This position is accountable to provide leadership, development and coaching for the plant quality organization. The role reports to the Senior Director of Quality Operations and serves as a member of the site leadership team.
This position contributes to WW functional strategy and priorities and ensures effective deployment within the plant. Equally, the Site Quality Leader will be expected to promote the creation of a culture of Quality throughout the plant
- Responsible for developing and maintaining plant strategic quality and compliance plan and policies.
- Accountable for the effective execution of processes carried out under departmental leaders by prioritizing and managing people, resources and budget to accomplish expected requirements and performance.
- Engage and provide leadership directions/objectives, coaching and personal development of Associates to perform to their best ability and meet both personal and plant objectives
- Define framework for department objectives, operation schedule, processes and budgets.
- Act as the plant “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.
- Build an influential and effective network and communication with WW Quality and Regulatory functions, other plant Quality Leaders and other key WW functions (R&D, Engineering, Supply Chain, etc.) in order to ensure alignment around global and local priorities.
- Build an influential and effective network and communication with plant leadership team members in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.
- Accountable to successfully manage quality issues.
- Accountable for identifying quality improvement opportunities within operations and partnering with peers in Manufacturing, Engineering, and Supply Chain and at other sites to develop and implement solutions – evaluate, propose and implement new processes and technologies as alternatives to optimize efficiencies in the departments.
- Ensure that site quality organization is staffed, organized and resourced to ensure it can fulfill its obligations to comply with cGMP and procedures.
- Mentor and develop department personnel, including supervisory / management staff.
- Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations.
- Manage performance issues and solicit the appropriate input from HR and management – write and administer performance appraisals on time and in a thorough and thoughtful manner.
- Direct overall operational leadership in planning and management of quality systems and activities, including resource management and vendor management, which includes the following:
- Validation program
- Internal and customer quality audits
- Compliance audit
- Corrective and preventive action program (CAPA board)
- GMP training program
- Quality engineering
- Change Control
- Document Control
- Complaint management
- Implement corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations.
- Interface with external customers and FDA/EMA during audits and inspections.
- Other duties as assigned
QUALIFICATIONS AND REQUIREMENTS
This position has the following educational requirements:
Bachelor's Degree: Technical or science related field.
Graduate Degree (MBA, MS, PhD, etc) preferred.
•10 years+ experience in pharmaceutical/biopharmaceutical manufacturing.
•Must be familiar with 21CFR parts 820 (QSR), 210/211, ISO9001, 13485 and having lead/participated in related audits & inspections.
•10 years+ in plant Quality.
•Experience in either production or engineering management, preferably including multi-country / multi-cultural experience.
•Production or engineering management preferred.
•Multi-country/multi-cultural experience preferred.
Skills and Certifications [note: bold skills and certification are required]
10 years Quality Operations in Pharma or Medical Devise Manufacturing facility/PLANT QUALITY
Proven leadership experience. Ideal candidate will have 5-7 years in a leadership role
Base Salary - $140,000 to $150,000
7+ to 10 years experience
Seniority Level - Mid-Senior
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Ideal Candidate, Ideal candidate will have leadership experience in a Pharmaceutical or Medical Device Manufacturing plant.
Big plus if candidate has led 100-1000 direct reports.
10+ years in PLANT QUALITY