Log In
Sign Up
Description
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 several 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.
The Director, Quality Control sets policies, institutes and assures adequacy of all quality control systems and process, assures the product specifications, methods are complete and accurate. The position holder structures the Quality control organization to accommodate growth and change. The incumbent consults and advises with all other internal departments, customers, and regulatory agencies, ensures that corporate policy and regulatory requirements are adhered to, as well as ensures decisions are made within the intent of cGMP, customer, and regulatory requirements. Contacts typically involve working with and influencing others in the solution of work and compliance problems that may be of a highly controversial nature, or coordinating two or more independent groups to achieve objectives that may have business unit wide impact.
The Director, Quality Control is accountable for Analytical testing of BI product (Biosimilars and NBEs – New Biological Entities, Combination Products) as well as CMB (customer manufacturing business) products and supporting materials manufactured in the Fremont facility and where Fremont tests for another manufacturing site. Accountability for this role includes coordination of testing with contract laboratories and management of the QC laboratories at the Fremont site. In addition, this role is accountable for collaboration with Boehringer Ingelheim process science global material service center, and external customers to transfer in/out and develop quality testing methods.
The Director, Quality Control is responsible for ensuring efficient workflows for regulatory assessment of process changes, as well as authorship, review, and timely submission of regulatory documents to meet compliance requirements for clinical and commercial manufacturing. The incumbent provides overall leadership responsibility for the Quality Control Organization and is a member of the Site Quality Leadership Team assuming responsibility for the leadership and governance of Quality topics at the site.
Duties & Responsibilities
• Plans, directs, and manages the work of the quality control organization to meet delivery, quality & efficiency goals.
• Effectively leads, drives, and manages changes to business needs.
• Directs activities of the Quality Control Organization within the Site and network priorities Framework.
• Sets direction and priorities of local activities.
• Manages budgets accordingly to assign appropriate resources to meet department objectives.
• Assures completion of duties as agreed upon and understood.
• Final authority and responsibility for all Quality Control decisions.
• Ensures that the right skills and capabilities of people in the Quality Control function are developed to enable the organization to be flexible/adapt to the dynamic business conditions.
• Sets the structural strategy for Quality control.
• Directs the Quality control organization to effectively identify and execute processes and procedural changes to improve quality control process, performance, compliance, delivery, and productivity.
• Plans, defines, sets requirements, assures implementation, and organizes systems to meet all GMP, BIFI, BI-Corporate and customer needs for GMP and QA activities, by written and verbal communications to all appropriate groups.
• Defines Quality metrics, monitors them and initiates appropriate actions if needed.
• Actively engages in the identification, sharing and adoption of shared practices between sites/offices.
• Implements/supports business process for continuous improvements in all areas of quality control.
• Provides Analytics documents for regulatory submissions (IND/CTAA, NDA/MAA.
• Ensures effective systems in place to maintain alignment between dossiers and analytical procedures/methods.
Requirements
• Bachelors of Science in Chemistry, Biopharmaceuticals, Biology or closely related science degree, Master level degree highly preferred.
• Minimum of twelve (12) years quality oversight experience in the pharmaceutical industry or closely related equivalent.
• Minimum of five (5) years’ experience with parenteral products.
• Experience should also include lab work, material inspection & release, supervision, validation.
• Minimum of five (5) years prior management experience.
• Regulatory Affairs experience with development of and filing of Analytics CMC sections of product applications, representation of site activities during regulatory audits highly sought after.
• Must have prior experience with support of internationally licensed products (MHRA and EMEA besides FDA).
• Requires excellent interpersonal, investigative and implementation skills.
• Demonstrated influencing, relationship building, and effective facilitation and change management skills required.
• Excellent communication skills with the ability to build rapport with management and employees and contribute to all aspects of the organization desired.
• Must be a strong leader with proven ability to engage, motivate, and develop the workforce.
• Organizational change management skills desired for this role.
• Ability to handle multi tasks and provide the leadership to implement solutions to complex problems using the best available technology.
Eligibility Requirements:
• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.
Compensation Data
This position offers a base salary typically between $165000 and $287K. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here.
