SR AD, New Product Transfer
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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Senior Associate Director, New Product Transfer is responsible for product quality, internal regulations and external regulatory compliance for products transferring from Global Innovation to Global Supply. This role leads the Quality and Compliance elements to ensure and execute all matters related to new product transfers from Global Innovation to Global Supply (analytical and process). This role will ensure completion and execution of the CSS as well as provide expertise and input into the strategy.
Duties & Responsibilities
- Provides technical-regulatory expertise and leadership to multidisciplinary projects for production/analytical transfer or for existing drug products.
- Ensures compliance of CMC sections and other regulatory documents that are submitted to global regulatory agencies meet the required the relevant standards.
- Provides strategic Quality and Compliance oversight for responses to incomplete letters or requirements, related to new product registrations and transfers.
- Leads Quality and Compliance strategy with production teams and regional Q Heads to ensure successful new product transfers.
- Provides Quality oversight for protocols and reports for new products.
Requirements
- Bachelor's degree in Pharmaceutics, Chemistry, Biology, other natural sciences, Business Administration, Supply Chain Management, Economics or related field required.
- In addition to bachelor's degree, a minimum of ten (10) years of professional experience in different functions within the bio-/ pharmaceutical industry.
- Experience must be inclusive of at least three (3) years leading projects or teams with varying backgrounds as well as international/intercultural negotiations skills, and/or international exposure in daily business (>50% of international business/customers/staff).
- Decision taking and strategic thinking skills
- Excellent communication skills and fluency in English.
- Excellent project management capabilities and experience.
- Strong team player in cross-functional environment, incl. conflict resolution skills.
- Strong interpersonal relationship skills.
- Good presentation skills.
- Compliance & regulatory knowledge.
- Financial knowledge (e.g. CCM, COGS/International Costs, NPV, profitability) preferred.
- Experience in Boehringer Ingelheim (or other companies) AH or HP Operations network a benefit.
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.