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Senior Specialist SQM

Company: Bayer
Location: Berkeley
Posted on: June 6, 2021

Job Description:

**Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.**

**Senior Specialist SQM**

**YOUR TASKS AND RESPONSIBILITIES**

The primary responsibilities of this role, Senior Specialist SQM, are to:

+ Be contingent on the relevant experience of the individual along with the current configuration of the group;

+ Enhance opportunities for cross-training and flexibility in terms of day-to-day scope;

+ Be driven by development needs/interests, career path and current department configuration;

+ Lead the overall Supplier Management Program;

+ Provide oversight for the overall annual surveillance and audit schedule, publish the approved supplier list and manage the various databases to support SQM programs;

+ Perform audits as required, manage third audit service providers and support training for new auditors or specialists;

+ Lead the overall Supplier documentation program;

+ Draft new Quality Assurance Agreements (QAA) and templates;

+ Draft Raw Material Specification (RMS) documents and templates;

+ Manage the systems for document control and routing, define the annual QAA program strategy and define and track metrics for overall adherence;

+ Lead the overall Supplier Change Notification Program;

+ Oversight for the notification inbox and tracking system, assign records, evaluate and process notifications;

+ Define, track process metrics, evaluate and implement process optimizations;

+ Drive the Supplier Qualification program;

+ Publish the approved supplier list, create and manage records in the qualification database;

+ Perform research and compile supplier qualification documentation;

+ Drive the Quality Assurance Agreement (QAA) process;

+ Partner with affiliates and negotiate with suppliers on new agreements;

+ Manage documents in the global contract system;

+ Track process metrics, perform risk assessments for new suppliers and amend QAAs as required by the annual program;

+ Drive the supplier Audit Program execution process;

+ Perform external supplier audits as a qualified lead auditor, enter and manage audit reports in the global reporting system;

+ Perform follow-up with suppliers for corrective actions and maintain lead qualification through continuing education;

+ Drive the Supplier Change Notification evaluation program;

+ Manage the supplier notification inbox and associated tracking system;

+ Perform initial screening and evaluations of notifications;

+ Process changes in the relevant change control systems based on notification impacts and track metrics associated with evaluation and record processing;

+ Drive the Raw Material Specification (RMS) program;

+ Draft new specification documents and review technical content;

+ Provide oversight for the specification document management system, partner internally and negotiate with suppliers to approve specification documents;

+ Oobtain internal/external approval for specification documents and upload to SAP;

+ Support the supplier qualification program;

+ Perform research on supplier backgrounds and compile qualification packets;

+ Access and update records in the relevant qualification databases and provide feedback to requestors on qualification documentation;

+ Support the supplier documentation program;

+ Perform QAA risk assessments, field questions about QAA content and support QAA amendment process;

+ Route new specification documents internally and externally to obtain approval;

+ Upload approved specification documents to SAP and perform review of specification documents against the supplier certificates;

+ Support the supplier change notification program;

+ Write and revise SOPs to align with CMS documents;

+ Present in agency inspections and serve as a site representative on initiatives to provide guidance on supplier oversight compliance;

+ Train and provide guidance to junior associates in processes as required.

**WHO YOU ARE**

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

+ Bachelor's degree in a scientific/ technical field with at least eight years of experience in Quality or Manufacturing In pharmaceutical operations OR Master of Science with at least four years of related experience OR Ph.D. with at least two years of related experience OR equivalent experience;

+ In depth knowledge of Global Manufacturing Practices (GMP);

+ Able to review and discuss governing regulations, precedent interpretations and current regulatory trends;

+ Proven ability as a team player and leader;

+ Excellent interpersonal skills;

+ Able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations;

+ Proven ability to lead cross functional teams;

+ Ability to independently recognize opportunities and the need for business and process improvements;

+ Ability to multitask and support changing priorities;

+ Strong written and oral communication skills, good presentation and influencing skills;

+ Strong ability to plan and prioritize complex and conflicting objectives to meet various goals under different SQM programs.

Preferred Qualifications:

+ CSQP, CQA or CMQ/OE;

+ Experience in Biotech.

**YOUR APPLICATION**

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

**Location:** United States : California : Berkeley

**Division:** Pharmaceuticals

**Reference Code:** 383161

**Contact Us**

**Email:** hrop_usa@bayer.com

Keywords: Bayer, Berkeley , Senior Specialist SQM, Other , Berkeley, California

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