Alpha 9 Oncology
Senior Director, Quality Assurance
Alpha 9 Oncology, Boston, Massachusetts, us, 02298
Senior Director, Quality Assurance
About Us
Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.
Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.
Position Summary Alpha-9 is seeking a Sr. Director, Quality Assurance, to join our growing organization. The Sr. Director, Quality Assurance will establish our Quality Assurance team in support of early phase clinical activities. This hands-on role will be responsible for implementing a GxP (GCP/GLP/GMP) compliant Quality Management System, performing all required functions of the Quality Unit, and building a Quality Assurance organization.
This is a pivotal role in an early-stage company, and we are seeking a candidate with the desire to build and lead a high-performing team of colleagues as the company grows and advances its pipeline.
Some specific duties and tasks include, but are not limited to, the following:
Conceptualize, implement and manage quality assurance and compliance systems fit for an early clinical stage biotechnology company – including a combination of authoring, reviewing, and approval of policies and SOPs in collaboration with key stakeholders.
Oversee continuous improvement of quality processes and procedures.
Recruit, lead, and mentor direct reports, to ensure execution against short- and long-term objectives.
Establish and manage Quality and Compliance Training program for GxP employees and contractors.
Qualify and manage relationships with contract research and manufacturing organizations. This includes the assurance of compliance and quality of operations performed by these organizations, as well as regulatory inspection support.
GMP vendor Quality oversight, including product batch records, manufacturing investigations, vendor product release, stability programs, analytical method qualifications, etc.
Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with functional leaders.
Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate.
Responsible for building and maintaining a high-trust relationship between Quality and the rest of the organization, while ensuring Quality is viewed as an integral thought partner and creative problem solver across all levels and functional areas in the organization.
Qualifications:
BS with a minimum of 10-12 years related experience; or MS with including a minimum of 8 years within QA. Previous experience managing people, or a function required, experience leading other leaders is strongly preferred.
Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents.
Experienced in the implementation of phase-appropriate Quality Management Systems.
Prior experience with patient specific batch manufacturing is preferred; radiopharmaceutical experience is a plus.
Strong leadership experience managing direct reports, talent acquisition, team development and influencing in a matrix environment.
Experience partnering with CROs and CDMOs.
Willingness to travel to facility locations as needed.
Excellent interpersonal skills, clear and concise both verbal and written communications. Demonstrated ability in building relationships with both internal and external partners.
What’s in it for you:
Competitive Salary, Bonus, and Equity
Medical, dental and vision insurance
Commuter Reimbursement
Retirement Plan with 3% employer match
20 vacation days
18 Holidays
5 Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Technology Allowance
Impactful rewarding work
Location: Boston, MA (Hybrid)
Email us at careers@a9oncology.com
#J-18808-Ljbffr
Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.
Position Summary Alpha-9 is seeking a Sr. Director, Quality Assurance, to join our growing organization. The Sr. Director, Quality Assurance will establish our Quality Assurance team in support of early phase clinical activities. This hands-on role will be responsible for implementing a GxP (GCP/GLP/GMP) compliant Quality Management System, performing all required functions of the Quality Unit, and building a Quality Assurance organization.
This is a pivotal role in an early-stage company, and we are seeking a candidate with the desire to build and lead a high-performing team of colleagues as the company grows and advances its pipeline.
Some specific duties and tasks include, but are not limited to, the following:
Conceptualize, implement and manage quality assurance and compliance systems fit for an early clinical stage biotechnology company – including a combination of authoring, reviewing, and approval of policies and SOPs in collaboration with key stakeholders.
Oversee continuous improvement of quality processes and procedures.
Recruit, lead, and mentor direct reports, to ensure execution against short- and long-term objectives.
Establish and manage Quality and Compliance Training program for GxP employees and contractors.
Qualify and manage relationships with contract research and manufacturing organizations. This includes the assurance of compliance and quality of operations performed by these organizations, as well as regulatory inspection support.
GMP vendor Quality oversight, including product batch records, manufacturing investigations, vendor product release, stability programs, analytical method qualifications, etc.
Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with functional leaders.
Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate.
Responsible for building and maintaining a high-trust relationship between Quality and the rest of the organization, while ensuring Quality is viewed as an integral thought partner and creative problem solver across all levels and functional areas in the organization.
Qualifications:
BS with a minimum of 10-12 years related experience; or MS with including a minimum of 8 years within QA. Previous experience managing people, or a function required, experience leading other leaders is strongly preferred.
Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents.
Experienced in the implementation of phase-appropriate Quality Management Systems.
Prior experience with patient specific batch manufacturing is preferred; radiopharmaceutical experience is a plus.
Strong leadership experience managing direct reports, talent acquisition, team development and influencing in a matrix environment.
Experience partnering with CROs and CDMOs.
Willingness to travel to facility locations as needed.
Excellent interpersonal skills, clear and concise both verbal and written communications. Demonstrated ability in building relationships with both internal and external partners.
What’s in it for you:
Competitive Salary, Bonus, and Equity
Medical, dental and vision insurance
Commuter Reimbursement
Retirement Plan with 3% employer match
20 vacation days
18 Holidays
5 Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Technology Allowance
Impactful rewarding work
Location: Boston, MA (Hybrid)
Email us at careers@a9oncology.com
#J-18808-Ljbffr