Associate Director, Quality

Company Description

Biosearch Technologies Inc. is the legal employer for this role.

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.

Job Description

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
• 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.

Qualifications

• Three or Four year Bachelor's degree in Chemistry, a related field, or a foreign equivalent plus 6 years of progressively responsible post-baccalaureate 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: $169,499 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

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