Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim’s Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.
We are continuing our rapid growth, investing $217m into the expansion of our capacity and capabilities, and creating approx. 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and Biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next 3-4 years, for which we can tap into Boehringer Ingelheim’s unique experience of having brought 31 biologics to market globally.
Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.
Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients!
The Director, TechnicalCompliance and Qualification manages and oversees all activities to provide newas well as maintain existing assets in a qualified state, and ensurescompliance within the scope of work of the BI Fremont Engineering &Technology department. By managing this operational function and group ofqualification and compliance engineers and in collaboration with siteoperations, site quality and regional as well as global partner functions, theDirector defines, controls and reports quality metrics, develops strategies forequipment and system qualification, identifies compliance gaps, definesmitigation measures, and supports internal and external audits. The role isaccountable to provide continuous oversight on quality metrics and qualitysystems adherence across all functions within BI Fremont Engineering &Technology, and as such acts on behalf of the E&T leadership team. Theincumbent provides business leadership to manage the resource planning,budgeting and financial reporting processes for compliance and qualificationactivities, develops contract plans to support investment projects as well asto provide operational support by leveraging best practices and a broad rangeof contracted service providers.
As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery,development and delivery of our products to our patients and customers. Ourglobal presence provides opportunity for all employees to collaborateinternationally, offering visibility and opportunity to directly contribute tothe companies' success. We realize that our strength and competitive advantagelie with our people. We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity and inclusion,mobility, networking and work-life balance. Our competitive compensation andbenefit programs reflect Boehringer Ingelheim's high regard for our employees.
- Provides strategic direction and functional leadership, oversight and coordination for Technical Compliance and Qualification. Establishes roadmap, and sets priorities together with site functions.
- Accountable for the economic, timely and qualitative delivery of qualification strategies, plans and execution of significant, multiple complex qualification/validation projects in support of the overall BI Fremont engineering project portfolio.
- Accountable for monitoring of all E&T owned quality metrics, and to develop mitigation plans and actions in cooperation with all E&T functions.
- Provides mentoring to E&T management to ensure technology and resources required to meet production demands is implemented.
- Accountable for the department annual budget and quarterly forecasting processes. Manages head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.
- Accountable for Technical Compliance & Qualification services vendor selection, and the oversight of the vendor relationship and performance.
- Aligns and coordinates with regional contracting and procurement and regional sites to achieve synergies and cost efficiency. Reviews and approves cost estimates, sets up check and balance system.
- Actively engaged in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites. Implements/supports business process for continuous improvements.
- Develops and supports an empowered, high performing technical Compliance and Qualification organization with accountability for Talent Acquisition, Talent Management, Engagement, Training, Safety, and Career Development. Accountable for effectively leading, driving and managing change for the functional area in a rapidly growing, highly dynamic environment.
- Ensures Staff compliance with BIFI quality, compliance, safety, GMP, and regulatory standards at all times.
- Ensures staff are sufficiently trained to perform their job responsibilities, SOPs, cGMP and EHS accountabilities. Develops an organizational structure that will adequately manage the function's responsibilities. Coaches, mentors, leads and manages departmental employees.
- Ensures that training and other personal development programs are in place for succession planning and the development of subordinates.
- Ensure that performance opportunities are pro-actively managed through the Performance Management system.
- Bachelor of Science or Engineering from an accredited institution combined with experience in the biotech and pharmaceutical industry. Higher academic degree from an accredited institution (MSc, MBA) is beneficial.
- Experience in Biopharmaceutical Process and Utilities Engineering, Engineering Quality, Biotech Operations, Reliability Engineering, Cost estimating and controls, Project management. Job requires strong strategic thinking and vision within a complex business environment.
- Broad and long-term experience (15+ years) in various functions in biotech and pharmaceutical industry, with knowledge ideally gained in multiple fields such as engineering, biotech manufacturing, qualification and compliance, or facility management and operations.
- 10+ years senior leadership experience gained through leading leaders and employees.
- Management experience in achieving results and managing others to achieve corporate, site, and departmental objectives. Experience leading teams to maintain adherence to a demanding schedules, working with cross-functional teams, such as Quality, Process Science, Manufacturing.
- Experience with authoring and reviewing standard operating procedures, on-the-job-training, and other controlled documents.
- Experience with Quality Systems such as Deviation, CAPA, Change Control Systems required.
- Experience in troubleshooting, investigation, root cause and risk analysis in a CGMP environment required.
- Must have experience leading the implementation of technical and continuous process improvements.
- Experience in the establishment of safe practices in a CGMP environment required including expertise and knowledge in GMP engineering facilities and equipment design concepts in order to review engineering projects for compliance impact.
- Strong Project management skills.
- Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management.
- Skilled in strategic thinking, communication and negotiation fast decision making to ensure the daily business.
- Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment.
Must be legallyauthorized to work in the United States without restriction.
Must be willing totake a drug test and post-offer physical (if required)
Must be 18 years ofage or older
Who We Are:
At Boehringer Ingelheim we create value through innovationwith one clear goal: to improve the lives of patients. We develop breakthroughtherapies and innovative healthcare solutions in areas of unmet medical needfor both humans and animals. As a family owned company we focus on long termperformance. We are powered by 50.000 employees globally who nurture adiverse, collaborative and inclusive culture. Learning and development forall employees is key because your growth is our growth.
Want to learn more? Visitboehringer-ingelheim.com andjoin us in our effort to make more health.
Boehringer Ingelheim, including Boehringer IngelheimPharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim AnimalHealth USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC, andBoehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmativeaction employer committed to a culturally diverse workforce. Allqualified applicants will receive consideration for employment without regardto race; color; creed; religion; national origin; age; ancestry; nationality;marital, domestic partnership or civil union status; sex, gender identity orexpression; affectional or sexual orientation; disability; veteran or militarystatus, including protected veteran status; domestic violence victim status;atypical cellular or blood trait; genetic information (including the refusal tosubmit to genetic testing) or any other characteristic protected by applicablelaw.