Principal Specialist, QC Project Management

Company: Jobleads
Location: Fremont
Posted on: May 3, 2021

Job Description:

Job Description - Principal Specialist, QC Project Management (212050) 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. 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 over $200m into the expansion of our capacity and capabilities, and creating approximately 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 couple of years, for which we can tap into Boehringer Ingelheim's unique experience of having brought 30+ 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! #LI-MS1 *I-SF1 PDN1 Description: The Principal Specialist in Quality Control (QC) Project Management manages QC deliverables on assigned biotechnological, complex projects for the captive use business and/or contract manufacturing business including client management. This position will perform planning, controlling, monitoring and reporting on quality control deliverables for projects and keep an analytical oversight of the assigned project working with global partners and customers. The incumbent has cross-functional project management responsibilities interfacing with operations, international project management, process science, supply chain, engineering & technology and the BI Innovation Unit. Other main responsibilities will include MSO (management system ownership) for the OOS process and the stability process, escalation of project resource conflict within the Quality function and representation of QC project topics in inspections and audits and being face to the client in the customer manufacturing and the captive use business. 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: Define work packages according to the project scope working with the CMC Project Leader. Acts as the primary QC member during the project phase for the external clients or BI IU team coordinating the flow of information from and to the client. Lead the analytical sub-team for individual projects through guidance on the contractual situation (CROs) as needed. Ensuring appropriate flow of information within the QC department including project updates at regular intervals. Informs the cross functional project teams on important decisions in a timely manner to support the project. Support the implementation of standards for QC project work at BI Fremont such as setting of specifications, sampling plans, analytical comparabilities, method transfer and validation, reference material characterization and release and stability analytics. Constant monitoring and continuously improving of critical processes. Contribute to definition of BI standards and processes on a global level and ensure local implementation.Lead or contribute to change management initiatives on a local and on global level. Local MSO for key processes (OOX and stability process). Responsible for the outsourcing of project analytics, review of data from contract labs. Project Management Systems and Execution. Support the establishment of appropriate project management systems, steering mechanisms and tools (plans, dashboards, reports) to generate, update and monitor work packages and project plans (including milestones and decision points) consistently. Work in a highly regulated area (FDA, EMA, ICH, EP, USP, CFR). Expert understanding and interpreting the applicable guidelines. Accountable for representing BI policies in government inspections, client audits, client negotiations, project specific events such as client meetings and in the project acquisition phase. Requirements: Bachelor's Degree from an accredited institution in Science (e.g. Biology, Chemistry, Biotech, Pharmaceutical Sciences or equivalent) with at least seven (7) years' experience in the pharmaceutical industry Master's Degree from an accredited with at least five (5) years' experience or a PhD from an accredited institution with at least two (2) years' experience in the pharmaceutical industry will also be considered Sound knowledge of biopharmaceutical production processes Prior experience working on global team is required. Project Management skills and project management systems required. Ability to interact and gain support of senior management. Good problem-solving capabilities and experience working with customer business. Intrapreneurship and decision-making. Open to changes and constant improvement. 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, global, and fast paced environment. Analytical expertise focusing on key analytical technologies used in Biopharma. Experience in biopharmaceutical product development and/or method development. Strong professional presentations experience with the ability to present data to and key stakeholders. Experience with Quality Systems such as Deviation, CAPA, Change Control Systems and investigations processes desirable. Ability to work in cross-functional teams and provide the leadership to implement solutions to complex problems within analytics using Project Management expertise. Agility to contribute in the development of a new organization, building efficiencies with the ability to build strong trusting relationships and build credibility quickly. Strong Strategic thinking ability and business judgment. Ability to resolve conflicts with team members and cross functionally. Excellent communication skills with the ability to build rapport with management and employees and contribute to all aspects of an organization. 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 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. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc.is an equal opportunity and affirmative action employer committed to a culturally diverse workforce.All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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