QA Compliance Specialist

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

QA Compliance Specialist - GMP Processes & SQM - Berkeley, CA 

QA Compliance Specialist – GMP Processes & SQM – Berkeley, CA

PURPOSE

Support key Compliance topics including Supplier Quality Compliance, Training, Documentation to ensure quality services are provided so that Bayer can manufacture safe and compliant products. Key activities could include coordination with global Quality partners in QMS implementation, supplier qualification activities and Documentation and training systems management.

The QA Specialist provides support and their expertise for the successful of compliance related lifecycle activities through the evaluation, analysis and determination of Quality related documentation (e.g. internal audits, data integrity (DI), combination product, site compliance issues, regulatory inspection findings, Quality Management Review items, etc.) using scientific principles and thorough analysis against regulations and compliance minded thought processes which meet cGMP requirements within established timelines. 

They may support appropriate learning tools and training module development which promote consistency and performance improvement across the business.  Support and direction for documentation issuance and management of procedures and batch records may also be in scope.

YOUR TASKS AND RESPONSIBILITIES

For this role as a Specialist, it is expected that you Lead at least one of the following (1), Be a key contributor to at least one of the following (1) and support at least 3 of the following (3) activities within the QA Compliance, GMP Processes and SQC team:

• Supplier Qualification documentation: Support and coordinate activities with global SQM group providing feedback to requests or qualification documentation, including review of QAA content and revision process, Supplier Qualifications, Supplier Audits and Supplier performance review;
• 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;
• Raw Material Documentation: draft new specification documents and review technical content, provide oversight for the material qualification process, partner internally and negotiate with suppliers for deviation investigations related to raw material defects;
• Management of DI program: overseeing policies and procedures, risk identification and remediation of issues identified, internal/external observations received, taking on corrective actions to mitigate risks and reviewing discrepancy investigations;
• Site Compliance program: supporting or participating in Internal audits to execute the annual program; proposes/creates the risk based internal audit schedule; reviews and approves internal audit reports and the internal audit schedule; Engaging with site employees through QA on the floor activities; Participating in Compliance Council program initiatives; Coordinating compliance activities increasing site and employee accountability in ensuring Quality in every vial;
• Compliance site documentation: generation and maintenance of documentation related to combination product regulations and requirements (e.g. Design History File, Change Management process after Design Freeze, Co-author the Risk Management Files); Ensure Berkeley site QMS Chapter process alignment with GSOP/GOI documents, QMS chapter remediation and Partners globally with GSOP authors and provide feedback on reviews as necessary;
• Regulatory Intelligence: Responsible for Annual Product Review program (including YBPR and PMSR) organizing, compiling and editing document for submission to Regulatory; overall compliance training and regulatory intelligence program providing compliance related training and Locally drives the deficiency letter remediation process working with global Regulatory Affairs, supporting global RA requests and change control at the local level including license renewal requests. Serves as a liaison/ project manager between Bayer LRAMs from various countries and local subject matter experts to address deficiencies;
• Site Quality Management and Systems oversight: Leads the Quality Management Review process, compiling data from subject matter experts, submitting and reviewing to global quality and local presentation to senior; Responsible for oversight of Quality systems providing general support and oversight of effectiveness; reports out quality system data and updates sites on compliance to quality standards. Establish appropriate strategy for system usage; oversee all system changes and/or enhancement for the business. Approves and reviews user access for required systems;
• Documentation processing: Review and approval of procedures and batch records; Ability to retrieve and archive documents as required; Ensure procedures and batch records comply with legal and regulatory requirements and are aligned with corporate directives;  SME for documentation practices;
• Training Creation: Create and define training effectiveness strategy for programs ensuring that legal and regulatory requirements are met in alignment with company directives; Determine and maintain appropriate measures to track and trend training effectiveness and performance improvement;
• Manage and Maintain Training: Manage standardization and implementation of training curricula, processes and tools; Drive efficient, standardized reporting practices; Provide training statistics, trends and proposed actions to manager and customers. Ensure effective data and records administration and retrieval for the organization; Serves as the Subject Matter Expert for Training for internal and external audits and inspections including remediation of observations/gaps;
• Cross Functional Projects: Drive process innovation by establish strong partnership with client groups; ensures required inputs from critical business partners meet cGMP requirements within established timelines and provide value added solutions; Establish strong partnerships with client groups and represents QA in interactions with all Manufacturing, QA, QC, Production Planning & Logistics, enabling partner s, Supplier Auditors/Inspectors, and regulatory agency inspections.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Bachelor's degree in a scientific/ technical field or equivalent experience;
• Minimum 6 years of Quality or Manufacturing In pharmaceutical operations, preferably biotech.  Equivalent experience in combination with an MS 2+ years or PhD 1+ years or an equivalent combination of education and experience;
• Knowledge of GMPs;
• Must be familiar with audit operation and provide guidance based on the applicability of the regulations;
• Must be able to review and discuss governing regulations, precedent interpretations, and current regulatory trends;
• Proven ability as a team player, a Catalyst for innovation;
• Proven ability to lead cross functional teams;
• Excellent interpersonal skills;
• Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations;
• Strong written and oral communication skills, good presentation and influencing skills;
• Be Visionary; aligning daily activities with goals and expectations;
• The ability to independently recognize opportunities and the need for business and process improvements;
• The ability to multitask and support changing priorities;
• Strong ability to plan and prioritize conflicting objectives to meet various goals under different QA programs.

PREFERRED QUALIFICATIONS

• Bachelor's degree in a scientific/ technical field; CSQP, CQA or CMQ/OE.

Employees can expect to be paid a salary between $ 89,764.00 to $ 134, Additional compensation may include a bonus or incentive compensation (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. 

This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least

  YOUR APPLICATION   

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. 
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. 

   Bayer is an E-Verify Employer.      Location:United States : California : Berkeley    Division:Pharmaceuticals   Reference Code: Contact Us   

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