Associate Director Quality

Key Responsibilities

• Establish and maintain riskbased and fitforpurpose QMS. Develop implement and communicate quality policies and procedures across cGMP at Axolabs Petaluma.
• Assess cGMP regulatory compliance risks and implement mitigation strategies.
• Maintain and develop supplier quality management systems ensuring that suppliers meet regulatory requirements and LGC Axolabs standards.
• Establish new ways to improve the LGC QMS data integrity initiatives and facilitate operational and quality improvement projects.
• Present and lead regular quality reviews to leadership e.g. oversight of deviation event classifications batch record review timeliness and other GMP quality management system performance metrics. Report and escalate compliance issues to leadership.
• Collaborate with stakeholders to identify define and implement opportunities for improved eQMS platforms. 
• Manage and mentor a team of QA and QC professionals to work within a global vertically integrated organization.
• Work with subject matter experts to ensure that QC investigations follow regulatory standards.
• Maintain timely closure of deviations CAPAs and change controls.
• Provide directives and manage the personnel to assure that QC training is in a state of compliance with all LGC Axolabs and current industry and regulatory standards.
• Implement appropriate systems to enable the efficient operation of the QC laboratory. 
• Record and identify metrics to monitor current manufacturing processes and identify and implement process improvements.
• Represent the company at stakeholder and regulatory audits through clear and concise description of QC procedures laboratory practices and documentation.
• Represent QC/QA in crossfunctional and stakeholder meetings.
• Implement applicable regulatory guidelines and directives e.g. ICH USP 21CFR.
• Supervises two direct subordinates (AMS Manager Therapeutics and QC Manager).

Qualifications :

• Three or Four year Bachelors degree in Chemistry a related field or a foreign equivalent plus 6 years of progressively responsible postbaccalaureate experience in job offered or any chemical engineering/quality assurance related job titles.
• Applicant must possess 6 years of experience with the following: 1 Pharmaceutical or CDMO industries including experience with cGMP principles practices and standards; 2 GXP statutory requirements and regulations; 3 Review and approve investigations Change Controls CAPAs and Risk Assessments; 4 establishing overall quality systems and procedures for US FDA compliant manufacturing facilities; 5 being responsible for lot release operations and commercial batch dispositions; 6 Preparing interfacing hosting and leading customer and regulatory audits; 7 acting as a quality liaison for multiple product partnerships with Contract manufacturers customers and distributors; 8 Authoring Reviewing and establishing Quality Agreements with customers contract facilities & suppliers; 9 Approving/Rejecting finished product for distribution.
• 20 domestic travel required for regulatory conferences quality audits for raw materials and labs.

Additional Information :

The typical pay range for this role is:

Minimum: $169499  USD

Maximum: $212500 USD

This range represents the low and high end of the anticipated salary range for the Californiabased position. The actual base salary will depend on several factors such as: experience skills and location.

This position is eligible for a discretionary bonus program. Participation in the bonus program is not guaranteed and bonuses are awarded at the discretion of the company based on individual and company performance results.

ABOUT LGC:

LGC is a leading global life science tools company providing missioncritical components and solutions into highgrowth application areas across the human healthcare and applied market segments. Its highquality product portfolio is comprised of missioncritical tools for genomic analysis and for quality assurance applications which are typically embedded and recurring within our customers products and workflows and are valued for their performance quality and range. 

OUR VALUES

• PASSION
• CURIOSITY 
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES 

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age disability race color ethnic or national origin sex sexual orientation gender reassignment marital or civil partnership pregnancy or maternity religion or belief. Short listing interviewing and selection will always be carried out without regard to gender sexual orientation marital status color race nationality ethnic or national origins religion or belief age or trade union membership.

For more information about LGC please visit our website

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