Principal Specialist, QC Project Management, Fremont CA

BoehringerPRD; Fremont (CA); On-site; USD 128,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement savings opportunities

Paid time off & holidays

Disability and life insurance

Job summary

Boehringer Ingelheim is seeking a Principal Specialist in Quality Control (QC) Project Management to oversee QC deliverables on complex biopharma projects for captive use and CROs. You will plan, monitor and report QC activities, coordinating with global partners and customers.

The role interfaces with operations, international PM, process science, supply chain and BI Innovation. Strong MSO ownership for OOS and stability processes is required.

Qualifications

• Bachelor’s degree in Science with 7+ years in pharma.
• Advanced degree (MS/PhD) with minimum experience considered.
• Strong knowledge of biopharma production processes.
• Experience working on global teams and project management.

Responsibilities

• Define work packages with the project lead and coordinate QC with clients.
• Lead analytical sub-team and ensure timely project updates.
• Implement QC standards and validate methods and stability analytics.
• Contribute to global standards and lead change initiatives.
• Represent QC in inspections, audits and client meetings.
• Oversee project management systems, plans and dashboards.
• Ensure compliance with FDA/EMA/ICH guidelines.

Skills

Project management

Cross-functional leadership

Quality systems

Biopharma

Regulatory compliance

Analytical thinking

Communication

Global collaboration

Education

Bachelor’s Degree

Master’s Degree or PhD considered

Tools

Project Management Systems

Job description

Compensation Details

The base salary range for this position is $128,000 to $192,000. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, qualifications, and other factors permitted by law. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please click here .

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, 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.