(Archived) Director, Quality and Compliance

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 and Compliance will provide strategic leadership and oversight of the Quality & Compliance for global vaccine manufacturing and product distribution within the areas of Quality Assurance (QA), Quality Control (QC), Validation (process, equipment, cleaning and systems validation), Computer System Validation (CSV), Veterinary Quality Services (VQS), and Technical Training (ASTA, Operations, and QCI process and training improvements) for a complex bio-manufacturing site(s). The incumbent will ensure Quality operational excellence initiatives lead to sustainable processes that increase robustness and improve efficiencies. This role is responsible for Strategic planning, direction and leadership for all compliance related GXP training (cGMP), auditing of vendors (ACE), local contract manufacturers, internal audits and regulatory inspections for the site.

The Director, Quality and Compliance provides leadership and direction to site Operations related to implementing quality policies, strategic plans, systems and procedures that will assure purity, efficacy, safety and potency of all products manufactured or tested at the site. The incumbent provides technical leadership to various departments including, but not limited to, Commercial Operations, Marketing, Product Development, Global Innovation, and Regulatory Affairs for quality issues relating to current products, product launch, as well as ensuring the facilities registered /approved for worldwide production/distribution. This role serves as a focal point for regulatory inspections pertaining to, but not limited to, FDA, USDA, European Union, Russian, Canada authorities, Japan and MCA. Ensures compliance with all regulatory requirements relating to product quality by implementation of cGMPs and through education and training of the workforce.

The Director, Quality and Compliance provides technical and strategic leadership that drives end to end integration and facilitation of the quality manufacture of vaccines by ensuring that schedules, plans, equipment, and resources are horizontally and vertically integrated across key functional groups in support of quality, delivery, and compliance requirements. The incumbent is responsible for final regulatory approval of the site for all product categories for the following: testing, inspection and release of packaging components, raw materials, labeling, and finished products; product and process validation; quality documentation; contact manufacturing quality activities; and execution of release of export products, recalls, market withdrawals. This position may serve as a deputy for the Site Head for in his/her absence.

The Director, Quality and Compliance provides development tools and direction to area staff and hourly workforce to ensure efficient utilization of company resources. This role is responsible to lead training of personnel in scientific/ASTA/QC/GMP principles, project management, technical and business process requirements as well as responsible for ensuring key subordinates are identified and effective development plans are in place to ensure the success of the site through employee retention and succession planning.

Duties & Responsibilities

• Strategic Business Responsibilities: Establishes strategic quality and compliance initiatives for development and production of global products.
• Strategic Quality Development: As Part of site leadership team provides input into strategic objectives and direction for improvement to the operations team.
• Compliance responsibilities: Functions as a liaison between Global QA/International Regulatory Affairs for technical compliance issues pertaining to products sold in the USA and the 70+ countries registered worldwide.
• Responsible for resolving all product quality complaints and adverse events for products.
• Responsible for regulatory inspections such as FDA, USDA, EU, JMAFF, Turkey, Russia, MCA, Canadian and Australian authorities.
• Technical Training, Development & Performance Management Functions:
  • Directs operations training on cGMPs,9CFR, 22CFR Part11, EU GMPs.
  • Directs ASTA training for site and support of network.
  • Sets direction and provides leadership for cost effective compliance initiatives.
• Responsible for succession and development plans of employees within the Quality organization.
• Performance management accountabilities.
• Validation responsibilities: Provides leadership and direction to set policies and procedures in place to meet strategic company goals for Development and Production.
• Quality Assurance, Quality Control, Tech Training: Provides leadership and direction to pharmaceutical and biological functions relating to budget, vendor certifications, specification development, stability testing, release of components, raw materials and products.

Requirements

• Bachelor's degree in relevant scientific or business discipline.
• In addition to bachelor's degree, incumbent must have a minimum of ten (10) years progressive and broad technical experience and demonstrated competence in overseeing various quality and Technical Training functions within a cGMP organization or similar environment.
• Experience must be inclusive of a minimum of ten (10) years of leadership experience strategically leading large teams and complex projects.
• Additionally, experience must be inclusive of supporting business process excellence concepts such as Lean Six Sigma or Lean manufacturing practices.
• Candidate must have excellent leadership skills along with ability to work cross functionally globally with GI, GS, and global Quality colleagues.
• Must demonstrate proficiency in applicable global regulatory requirements including EU, cGMP, 9CFR.
• Experience working collaboratively in a matrix environment.
• Must possess a working knowledge of all business disciplines to ensure ability to “partner” with all functional departments of the organization.
• Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent communication skills, team player, organized analytical thinker with a high level of energy and self-motivation, excellent writing skills.
• Strong scientific and technical background and experience in all areas in the Biotech and Pharmaceutical industry desired.
• Demonstrated versatility in conflict resolutions, problem solving, and working effectively as a part of a cross functional team.

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.

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