Associate Director, Quality

ABOUT LGC AXOLABS:

Axolabs specialises in a new class of drugs whose active ingredients are chemically derived from DNA or RNA. They are called oligonucleotide or nucleic acid therapeutics. We use our many years of expertise to help our clients make them a success. Some of these drugs have already been approved and are being used successfully against diseases that were previously untreatable in some cases. New drugs from this class are added every year.

We believe in Science for a Safer World and are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization. LGC Axolabs is located in Petaluma, US, Kulmbach and Berlin, Germany.

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 in-process, 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 risk-based and fit-for-purpose 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 cross-functional and stakeholder meetings.
• Implement applicable regulatory guidelines and directives e.g. ICH, USP, 21CFR.

• 10+ years of experience with Pharmaceutical, Medical Device or CDMO industries.
• In-depth 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.
• In-depth 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 decision-making.
• 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

The typical pay range for this role is:

Minimum: $127,500  USD

Maximum: $212,500 USD

This range represents the low and high end of the anticipated salary range for the California-based 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 mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical 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 www.lgcgroup.com

#scienceforasaferworld