This position leads a team of highly skilled SME to manage key GMP functions in drug substance and drug product manufacturing operations including deviation management, change management, compliance management and the commercial trending. This role leads a team of highly skilled SMEs. This role is a key link between Quality and Manufacturing organizations to release product and manufacturing areas for production.
This role and his/her team owns complex cross functional improvement projects and ensures successful implementation of the area's continuous improvement initiatives. This includes development of a long-term strategic plan for continuous improvement in alignment with site goals. Incumbent provides technical expertise on Quality Assurance and Compliance standards and processes to team members; and provides input on strategy to the Associate Director Manufacturing Compliance, Manufacturing and Quality Compliance and Quality Assurance teams.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities:
- Leads and manages the work of the Manufacturing Compliance group to meet quality, productivity and efficiency goals and to achieve operation and quality goals and objectives. Accountable for effectively leading, driving and managing change in Manufacturing Compliance in a rapidly growing, highly dynamic environment.
- Leads group to thoroughly investigate major and complex minor manufacturing deviations. Collaborates cross-functionally to gain alignment on compliance and quality issues. Ensures that deviation investigation meet current quality standards and that risk based decisions are applied.
- Leads group to develop and control changes in the manufacturing area. Ensure that changes are defined, thorough, and controlled to ensure that validated status and areas are maintained. Implements changes that improve flexibility and innovation in the Manufacturing area. Provide manufacturing solutions to complex issues.
- Manages the Key Performance Indicator program for the Manufacturing organization. Compiles, organizes, and analyzes performance to continually seek improvement areas.
- Leads team to manage trending program for commercial products including but not limited to timely generation of statistical reports, trends, summary reports and expert analysis.
- Interview, hire, train, supervise, coach, motivate, develop and discipline Staff. Responsible for creating department goals and ensuring teams are on track to meet those goals. Assigns goals to meet scheduling requirements. Sets performance objectives and development plans. Monitor progress. Develop and train Managers and supervisors for growth and advancement.
- Requires a Bachelor’s degree from an accredited institution, preferably in a science or engineering related field with eight (8) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility. plus a minimum of fie (5) years’ experience managing/directing people in a GMP environment or clean room assembly environment
- In lieu of a Bachelor's degree from an accredited institution, will consider an Associate's degree, preferably in a science or engineering related field with a minimum of ten (10) years’ experience including minimum of five (5) years proven record of managing/directing people in a GMP environment or clean room assembly environment
- In lieu of a Bachelor's or Associate's degree, will consider a High school diploma/GED plus thirteen (13) years’ experience including minimum of five (5) years proven record of managing/directing people in a GMP environment or clean room assembly environment.
- Requires interpersonal, investigative and implementation skills.
- Ability to think strategically and has strong business judgment
- Demonstrated influencing, relationship building, and effective facilitation.
- Excellent communication skills with the ability to Influence Cross functionally.
- Ability to handle multi tasks and provide the leadership to a team.
- Experience in deviation management, change management, compliance management and the commercial trending.
- Experience leading teams of SMEs.
- Experience in managing continuous improvement initiatives.
- Some experience in strategic planning for continuous improvement
- Technical expertise on Quality Assurance and Compliance standards
- Ensures compliance of manufacturing processes and systems as well as department activities with national and international cGMP (e.g. FDA, EMA) and Company Policies, Procedures, Goals and Objectives.
- Follows all relevant department policies, procedures, SOP and other requirements and act at all times within the BI standards/ethics policies. Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating
- Participate in BI interactions with various governmental agencies/regulators and external auditors
- Strong understanding and appreciation for regulatory requirements and compliance standards under which the Fremont site is operating
- Coordination and communication between multiple departments, including Process Science, Quality, Engineering and other functional areas.
- Work is primarily directed at the site; however, may interact with colleagues at other USA and worldwide sites.