SR Specialist SQM, Fremont CA

Description

The Sr Specialist, SQM role offers a base salary typically between (90,000) and (147,000).  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. 

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 basic purpose of this role is to perform active quality management and quality oversight of the Biopharma GxP relevant material/service suppliers, including services of clinical and commercial GMP contract manufacturing organizations (CMOs) and contract laboratory organizations (CLOs). 

The Senior Specialist, Supplier Quality Management (SQM) will execute SOPs and processes that ensure the procured materials and services are aligned with the expectations of Boehringer Ingelheim Quality Systems, Quality Assurance Agreements (QAAs), and Clients' requirements and compliant with health agencies' expectations. This role will actively work on resolving issues that arise from the job execution in accordance with the approved SOPs.

This is an onsite position with flexibility. 

Duties & Responsibilities

• Participates in creation of the team standard operating procedures and uses the corporation's applicable computerized system (e.g., Go-Track) to execute the assigned tasks that may include: 
  • Quality management and oversight of the GxP relevant materials, service, and suppliers (including CMOs and CLOs), addressing the different phases of the supplier life cycle (e.g., audits).
  • Generation, review, negotiation and maintenance of Quality Assurance Agreements with CMOs, CLOs and suppliers. Note: this includes other BI sites inter-company QAAs.
  • Supplier/CMO/ CLO selections and (re)qualification processes, manufacturing and analytical, technical transfers to the CMOs/CLOs and material certifications.
• Can be delegated to act as the quality responsible person, first escalation point and source of quality guidance (e.g., material review board decision-making) to resolve quality issues triggered by interactions with the assigned suppliers or use of their materials and services. 
• Escalates issues to the immediate supervisor (and to other stakeholders as per the defined and approved escalation policies, e.g., reporting to the global functions, Supplier with the issue process) to resolve conflicts promptly and minimize risks to Boehringer Ingelheim.
• Handles and investigates deviations from established procedures per the applicable procedures and work cross-functionally with other relevant stakeholders to provide adequate and timely investigations. 
• Be qualified in the investigation process.
• Handles the assigned changes (e.g., supplier change notifications, process changes at the CMO) potentially impacting product quality or regulatory compliance per the applicable procedure.
• Acts as a subject matter experts/MSO at the site who is knowledgeable and continually trained on the applicable local and global procedures.
• Drives integration of BIFI with global platforms and ensures site representation in the relevant global forums and meetings.
• Communicates BIFI perspective to those forums and influences the global functions and MSOs to establish procedures that BIFI can practically implement and comply with.  
• Ensures active engagement in identifying, sharing and adopting shared practices between Boehringer Ingelheim sites/offices.
• Implements and supports business processes for continuous improvements.
• Establishes evaluation measures to monitor the performance of CMOs, CLOs, services, materials and suppliers (e.g., establishing key performance indicators and their follow-up methods to ensure meeting the KPI targets or thresholds, meeting in person with the CMOs, CLOs and suppliers at their locations to monitor performance and drive improvements, ensuring strict adherence to the established timelines in the QAAs).
• Performs necessary trending and escalations to the immediate supervisor. Introduces processes, systems corrections, and improvements (e.g., CMO and CLO development and proactive risk reduction measures).
• Periodically reports the status to the site's appropriate review forums that may include site senior leadership personnel.
• Performs additional duties as assigned within the scope of the quality function at Boehringer Ingelheim Fremont (e.g., prepares documentation supporting regulatory submissions, actively participates in site readiness activities for audits and inspections, and supports the compliance function during such audits).
• Represents BIFI during audits and inspections and defends BIFI practices, positions and decisions whenever challenged.

Requirements

• Bachelor’s Degree in a scientific / technical discipline.
• Minimum five (5) years’ experience in a life sciences or closely related industry.
• Systems skills (e.g., SAP / GoTrack); Experience in supply chain/supplier and material quality evaluation and design.
• Experience managing within a high-speed customer-oriented environment.
• Knowledge of all relevant industry standards and regulatory expectations.
• Ability and willingness to continuously improve local and global standards and drive towards improved compliance and quality.
• Excellent oral and written communication skills.
• Ability to motivate and mobilize staff.
• Must exercise rapid learning ability, attention to detail, excellent computer skills, team player, organized, analytical thinker with high energy and self-motivation.
• Ability to read, develop, and understand procedures and other controlled documents.
• Must have well-developed interpersonal skills to establish highly functional relationships with diverse personalities cross-functionally.
• Demonstrated proficiency in MS Office programs and associated computer programs.
• Ability to work in a team environment.

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.