Director, Quality Assurance – New Modalities, Antibody Drug Conjugate

📋 Description

• Lead Quality initiatives as a member of the New Modalities Quality team to guarantee comprehensive quality oversight essential for enhancing agility and expediting market entry, while ensuring compliant supply of new modalities pipeline products to global markets.

• Remain informed about current GMP standards and industry developments as outlined in global regulations and industry benchmarks, along with trend analysis.

• Maintain an expert-level understanding of these specialized fields, with a particular emphasis on Antibody Drug Conjugates.

• Offer guidance and mentorship to manufacturing teams regarding new modalities quality oversight requirements and Health Authority GMP standards.

• Assess the existing Quality Management Systems of the company and partners for seamless integration and identify potential synergies while ensuring adherence to GMP standards.

• Ensure compliance with corporate policies as well as other divisional guidelines related to product quality management.

• Establish an effective QMS, guaranteeing comprehensive quality oversight of new modalities products produced at our company and external partner sites.

• Collaborate with our company's Manufacturing Division QMS team for necessary updates to the QMS.

• Partner with teams across the organization (Research, Manufacturing, and Commercial) to comprehend the distinct requirements for new modality products and ensure these are met through tailored quality management oversight.

• Assess the Quality and compliance capabilities of external partners and identify associated risks.

• Collaborate with internal teams and external partners to mitigate risks as needed.

• Ensure that facilities and processes comply with regulations and facilitate the approval of new modality regulatory submissions.

• Maintain a close working relationship with the Quality departments of our research and manufacturing divisions, as well as the Technical CMC teams, for comprehensive quality oversight and support of new modalities products.

• Assist in the development of and report on quality metrics that measure operational effectiveness to the relevant governance forums within the research and manufacturing divisions.

• Drive continuous improvements to the new modalities QMS to uphold GMP and Regulatory compliance.

⛳️ Requirements

• Bachelor’s degree in a Life Science Field, Engineering field, or a related relevant discipline.

• At least ten (10) years of experience in the pharmaceutical industry.

• Experience with or direct support in the manufacturing of Antibody Drug Conjugate (ADC) products.

• Experience in managing people through change.

• Background in quality operations and/or compliance.

• Proven leadership, communication, interpersonal, and negotiation skills, particularly with cross-functional teams.

• Ability to grasp and understand the technical aspects of new processes to ensure effective Quality oversight.

🏝️ Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation.

• Compassionate and sick days.