Analyst V, GMP Audit & Compliance (US Remote Possible)

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Job description

Description:
The Analyst V, Compliance position is responsible for the Third Party Quality Management in Development for assigned third parties and development projects. This includes an overview about the supply chain of Investigational Medicinal Products. The function comprises quality related GxP activities with a focus on GMP and GDP at BI's external partners. The supplier qualification and auditing process follows global BI procedures and systems. Therefore, interaction / reporting within Global Quality Development is standard.
The main purpose of this position is to implement the Boehringer Ingelheim (BI) Regulatory Compliance Program designed to assure the adherence of facilities, operations, studies, reports, and practices to regulations (e.g. FDA, EMEA, NRC, DEA USDA) as well as to BI global and local Standard Operating Procedures (SOPs), policies, regulatory guidelines and good scientific and documentation practices. The position is also responsible for informing the management of deviations from the cGMP, GLP, other Regulations observed during audits/inspections, and to recommend appropriate corrective action when necessary and to verify that appropriate corrective actions have been implemented that adequately address any deviations reported during inspections.
Ensures that all procedures and processes, in preparation for regulatory inspections are well documented and supported by ongoing training and monitoring.
Builds culture of compliance and quality by implementing operational excellence and quality management programs.
Develops and manages business processes that optimize productivity, quality, compliance, and resource utilization across the development functions.
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 a number of 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.
Duties & Responsibilities\:

• Lead teams to develop policies and procedures for compliance evaluation of regulated activities in area of responsibility within R&D

• Acts as primary QA interface to suppliers, including but not limited to contract manufacturers, external laboratories and distributors
• Assumes responsibility for supplier qualification and auditing activities according to applicable internal and external regulations.

• Organize and lead process improvement projects locally and/or internationally (as required); Foster a work environment that supports quality, productivity and compliance; Partner with Research, Development and other business partners to prioritize and manage process improvement projects
• Lead and conduct audits, issue audit reports, and perform follow-up actions as assigned; Oversee investigations of compliance issues noted during audits and inspections or otherwise observed or reported
• Review/audit compliance documents, SOPs and validation protocols as assigned; Report findings to Research or Development management
• In the absence of the manager or when assigned; organize and host inspections and audits by regulatory agencies, BI compliance groups, and consultants in area of responsibility; Investigate and resolve moderately complex observations noted during audits / inspections; Lead and organize inspection readiness activities
• Maintain expert proficiency in technical and non-technical (e.g., interpersonal skills) skills; Maintain proficiency on regulatory compliance issues through industry contacts, journal articles, professional meetings and seminars
• Model and coach colleagues in effective and constructive communication behaviors and interactions with technical departments both orally and in writing
• Train new personnel as required and develop and implement training programs in the regulatory requirements as requested. Acts as a resource for colleagues with less experience. Assume the role of manager when requested.
• Manage programs designed to ensure regulatory compliance of Quality Systems and foster an environment for R&D QA personnel to initiate improvements; Perform all company business in accordance with all regulations (e.g. FDA, EMEA, USDA, NRC, DEA) and company policies and procedures
• Domestic and International business travel is required

Main Requirements\:

• Bachelor's Degree with a minimum of 8 years pharma experience in a GMP regulated area or a Master's Degree with a minimum of 5 years pharma experience in a GMP regulated area.
• Experience in performing or hosting GMP Audits
• Experience with biological products (quality assurance, manufacture or analytical testing in development or commercial manufacture of biological drug substances or drug products) is preferred
• Advanced/In-depth knowledge of international regulatory guidelines (EU, US, ICH) and quality / GMP standards; acts as a resource for colleagues.
• Travel Requirements\: 20% - 30% (Domestic/International)
• Recognized as expert by clients and colleagues
• Requires minimal supervision
• Works independently with minimal guidance
• Ability to make decisions for department in manager's absence
• Independent problem detection and implementation of problem solution
• Ability to formulate strategies for performing regulated activities based on knowledge of regulations and guidance
• Excellent conflict resolution and negotiation skills
• Independent representation of department
• Excellent organization skills resulting in the ability to be self-directed and manage multiple cross functional programs and projects
• Excellent verbal and written communication skills; good interpersonal skills
• Excellent leadership and mentoring skills
• Knowledge of process improvement concepts and applications in R&D environment
• Respectful interactions with individuals with diverse views or backgrounds
• This position is eligible for US Remote-based work. However, a regular presence such as one week per quarter in Ridgefield or another appropriate interval is mandatory.

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
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.

Compensation\:
This position offers a base salary typically between ( $120,400) and ( $150,500). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.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.
Who We Are\:
At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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