Compensation Data

This position offers a base salary between $170,000.00 and $269,000.00.

Description

The Director, HP Strategic Network Quality & Compliance is responsible to support the Human Pharma (HP) network sites and the Exec. Director of Inspection Lifecycle Management in maturing inspection readiness and inspection life-cycle management strategy. This role leads and influences US and global HP network teams by effectively interpreting and supporting deployment of cGMPs and authority quality system regulations. The position holder drives and influences the HP network in the implementation of the inspection readiness program to assure successful inspection performance to obtain/sustain site licenses/GMP certifications to launch/distribute products in the specified markets.

The Director, HP Strategic Network Quality & Compliance maximizes synergies between global HP sites and ensures the lessons learned are leveraged for sustainability of market access. The incumbent is responsible to proactively identify potential risks associated with evolving regulatory inspection trends and drives to implement quality system improvements to assure positive Authority Inspection performance. This role will enhance authority inspection knowledge through site specific consultation, project management, baseline assessment and training.

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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's 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.

Duties & Responsibilities

Provides evidenced-based strategic direction to identify and address issues and opportunities that may impact inspectional success and/or market access.
Maintains/sustains specific and current knowledge of regulatory (FDA, EMA, TGA etc.) regulations, guidance and requirements.
Responsible for inspection readiness strategy development, implementation and oversight of HP network sites based on industry trends, key learnings and industry best practices.
Implements well-documented and holistic approach ensuring coordination and alignment with stakeholders.
Develops and deploys tools, techniques to achieve defined readiness status.
Leads cross-functional/cross-cultural global expert teams involving QA, QC, Operations, DRA, Legal, external consultants etc. in actively soliciting team expertise and input in the development and execution of risk mitigation strategies leading to positive inspection outcomes.
Provides oversight, leadership, mentoring and consultation before, during and after inspections/audits.
Supports HP network sites in developing a sound response strategy and consult in review/rewrite of responses as needed.
Serves as a Global Quality/Compliance liaison for interactions with regulatory authorities, divisional and corporate quality, US and Global RA, Consultants etc.
Ensures activity alignment with Global and Divisional priorities.
Ensures development and effective implementation of key initiatives and strategies, aligned to Global Quality Initiatives.
Oversees development of tactical plans related to network sites and key inspections.
Engages and motivates resources to ensure that quality and operational objectives are met, ensures that corporate standards of excellence, company policies, compliance and ethical and compliant business practices are upheld.

Requirements

Bachelor's degree required with a preferred focus in Chemistry, Biology, Pharmaceutical Science, or related field.
Minimum of fourteen (14) years relevant work experience in a regulated pharmaceutical industry producing finished drug products (Biologics, Chemical). Experience can be a combination of Quality Assurance, Quality Control, Regulatory Compliance, Project Management, etc.
Requires demonstrated expert knowledge of FDA, EMA and ICH guidelines and regulations.
Requires demonstrated experience in leading/managing health authorities during inspections, interacting with regulatory inspectors in written or verbal formats.
Strong inter-cultural skills; international working experience.
Demonstrated ability to motivate and collaborate with cross-functional teams.
Demonstrated negotiation and influencing skills; smart risk taking and scientific decision making.
Ability to challenge status quo and communicate with candor, effectively with senior management across the HP network and within various cultures.
Strong communication skills (verbal and written) in English.
Preferred experience in Biopharma Operations and regulators overseeing Biologics compliance (i.e. CBER).
Preferred experience working directly or as ex-FDA in roles as Inspector, CMC reviewer in CDER, CBER etc., to leverage regulatory expertise and insights for enhancing inspection readiness and compliance.
Ability to travel domestically and internationally approx.40-50%.
Demonstrated broad understanding of pharmaceutical know-how to ensure compliance and quality requirements:
Pharmaceutical manufacturing & packaging knowledge preferred.
Preferred experience in storage and distribution of pharmaceutical products.

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.