Associate Director Quality

The role offers a unique opportunity for a quality focussed leader to oversee a team of 15 Quality Control and Quality Assurance professionals within the testing areas of inprocess release stability deviation events and investigations. The role will collaborate closely with Process Transfer Process Development and Manufacturing teams.

The Associate Director Axolabs Petaluma Quality will continue to embed a quality culture and mindset in all local drug development and manufacturing activities. Reporting to the Head of LGC Axolabs the Associate Director NAT Quality is responsible for the Quality Management System Quality Risk Management Quality Control Operations Quality Training and Supplier Quality Management.

This position requires knowledge and experience with quality assurance systems regulatory compliance and industry guidance ideally with an understanding of the requirements for the manufacture of Nucleic Acid Therapeutic API for clinical development. The candidate must possess both leadership qualities a deep understanding of cGMP and preferably some knowledge of Nucleic Acid Therapeutics.

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. Page 2 of 3 Associate Director Quality Axolabs Petaluma PB Edit 16 Jan 2023 1 Version No: 1
• 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.

Qualifications :

• 10 years of experience with Pharmaceutical Medical Device or CDMO industries.
• Indepth understanding and application of cGMP principles practices and standards.
• Prior experience and broad range of knowledge in Quality Compliance or a combination of experience such as Manufacturing Quality and Regulatory required.
• Indepth knowledge in Nucleic Acid Therapeutic regulations and guidance preferred.
• >5 years management level experience with ability to develop staff.
• Excellent interpersonal and communication skills
• Ability to influence stakeholders and drive decisionmaking.
• Proficient in MS Office Software such as Excel Word Outlook and PowerPoint.
• Experience in eQMS eBR LIMS is a plus.
• Ability to travel up to 20 as required
• The position requires some knowledge of CMC analytical technology and oligonucleotide manufacturing processes

Education

• Advance scientific qualifications with at least 6 years of experience in a relevant functional area

Additional Information :

The typical pay range for this role is:

Minimum: $127500  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

#scienceforasaferworld