Senior Associate Director, Compliance Management (Remote)

Boehringer Ingelheim Pharmaceuticals, Inc.; United States; Remote; USD 167,000 - 250,000; Full time

Job summary

Boehringer Ingelheim GmbH in the United States is seeking a Senior Global Quality and Compliance Lead to shape quality strategy and ensure continued regulatory readiness across Medicine functions. You will lead cross-functional teams, apply GxP principles, and drive proactive compliance.

The role requires extensive experience in QA, CAPA, NC, and risk assessment, plus strong collaboration with regulators and internal stakeholders.

Qualifications

• Minimum of twelve (12) years in pharmaceutical/CRO industry.
• Minimum of seven (7) years’ experience in Clinical Operations and/or other BI Medicine functions.
• Minimum of five (5) years’ experience in Non-Compliance (NC) and Corrective Action / Preventive Action (CAPA) management processes, incl. Root Cause Analysis methodologies.
• Eight-plus (8+) years of experience in GxP quality management system.
• Experience in interacting with Regulatory Authorities e.g. regulatory inspections
• Strong interpersonal, cultural, and communicational skills.
• Solution oriented.
• Strong organizational and project management skills.
• Travel as needed.

Responsibilities

• Defines and delivers training for NC/CAPA process and other compliance topics as applicable.
• Acts as cross-functional compliance expert: Provides GxP guidance as required; Ensures sharing of best practices within QM and Medicine business functions as applicable; Initiates updates of relevant process descriptions and guidelines as needed.
• Supports global quality issues, compliance topics and improvement initiatives: Supports teams to perform root cause analyses and identify adequate CAPAs; Ensures adequacy of effectiveness checks after actions; Supports teams with Quality tools and methods; Offers process analysis and optimization capabilities.
• When assigned: Supports IDE projects (In-Depth Evaluation and Due Diligence Process) by assessing GCP compliance; Supports Partnering projects when BI's GCP compliance is assessed by external potential future partners.
• If/when assigned to a Therapeutic Area: Defines and implements strategy for support of clinical development projects; Supports clinical development teams with trending and analysis; Gives recommendations based on risk assessments for continuous improvements.

Skills

GxP quality management

Regulatory inspections

CAPA management

Root Cause Analysis

Quality systems

Cross-functional collaboration

Travel willingness

Education

Bachelor’s or Master’s degree in a relevant field (e.g. MBA, MSc)

Job 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 Global Quality and Compliance Lead (Sr.GQC-Lead) leads the generation of timely and actionable outputs and knowledge that inform and drive quality strategy and operations for the assigned function(s)/area(s). In addition, applies proactive compliance, maintaining a high level of quality transparency within the organization, and fostering a culture of quality excellence.

When assigned to a Therapeutic Areas, the Sr.GQC-Lead supports the clinical development teams with trending and analysis, risk assessments and inspection readiness. This role provides GxP compliance consultancy to Medicine business functions as needed and supports global quality initiatives, quality issues, inspections, and compliance topics, as assigned. The incumbent develops best practices for compliance processes considering outside and inside view striving for innovation, effectiveness, and efficiency.

Duties & Responsibilities

• Defines and delivers training for NC/CAPA process and other compliance topics as applicable.

Acts as cross-functional compliance expert:

• Provides GxP guidance as required.
• Ensures sharing of best practices within QM and Medicine business functions as applicable.
• Initiates updates of relevant process descriptions and guidelines as needed.

Supports global quality issues, compliance topics and improvement initiatives:

• Supports the teams to perform a sound root cause analysis and to identify adequate CAPAs.
• Ensures adequate effectiveness checks after implementation of actions.
• Supports the teams with respective Quality tools and methods.
• Offers process analysis and optimization capabilities as applicable.

When assigned:

• Supports IDE projects (In-Depth Evaluation and Due Diligence Process) by assessing GCP compliance.
• Supports Partnering projects when BI's GCP compliance is assessed by external potential future partners.

If/when assigned to a Therapeutic Area:

• Defines and implements strategy for support of clinical development projects.
• Supports clinical development teams with trending and analysis.
• Gives recommendations based on risk assessments for continuous improvements.
• Supports teams in compliance questions and global improvement initiatives as applicable.

Requirements

• Bachelor’s degree and/or Master’s degree (e.g. MBA, MSc).
• Minimum of twelve (12) years in pharmaceutical / CRO industry.
• Minimum of seven (7) years’ experience in Clinical Operations and/or other BI Medicine functions.
• Minimum of five (5) years’ experience in Non-Compliance (NC) and Corrective Action / Preventive Action (CAPA) management processes, incl. Root Cause Analysis methodologies.
• Eight-plus (8+) years of experience in GxP quality management system.
• Experience in interacting with Regulatory Authorities e.g. regulatory inspections
• Strong interpersonal, cultural, and communicational skills.
• Solution oriented.
• Strong organizational and project management skills.
• Proficient knowledge in applicable regulations, company processes and procedures with ability to assess their impact.
• Responsive, knowledgeable, collaborative, trustworthy, assertive, and decisive.
• Travel as needed

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

This position offers a base salary typically between $166,600 and $250,000. 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.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com