MANAGER, QUALITY ASSURANCE
SCOPE OF POSITION
Zionexa is a dynamic and growing international company, developing and commercializing molecular imaging companion diagnostics (CDx’s) for targeted therapies in Oncology that will help clinicians find the right treatment for the right patient at the right time. Our goal is to improve patients’ pathways and overall quality of life.
The FDA has approved Cerianna (Fluorestradiol F-18) a molecular imaging agent for use in Positron Emission Tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Cerianna is the 1st FDA approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer.
This is an exciting time for Zionexa as we begin our journey. Come be a part of an outstanding international team, one that is striving to make positive impacts in peoples’ lives. As we begin with the launch of Cerianna, we are looking for an experienced Quality Assurance professional to join us on our journey.
The successful candidate will be responsible for: implementing the Quality Assurance System (QMS)in accordance with Company policies. The position will provide assurances to management that product quality requirements will have and have been met. The position will work with Zionexa’s Contract Manufacturers to implement manufacturing sites and monitor ongoing product quality. They will identify and initiate continuous process improvement initiatives and activities.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- The position will create, establish and maintain required quality documents and documentation including: cGMP’s, SOP’s, CAPA, validation and audits.
- They will develop and establish processes and practices to ensure the appropriate standards are in place.
- Perform clinical and vendor audits and investigations.
- Maintain site monitoring along with administering vendor qualification programs.
- Provide validation services and activities including gap analysis, remediation and execution for all compliance programs and processes.
- Develop, recommend and monitor corrective and preventive actions.
- Analyze data to identify areas for improvement in the quality system.
- Evaluate data and releases of Zionexa produced products that conform to Company, customer and regulatory standards.
- Review, analyze and release batch records.
- Annually or as needed, evaluate product data and write and/or review reports for approval by management.
- Participate in internal GMP audits.
- Participate and support on-site audits by customers, FDA and/or other regulatory agencies.
- May provide product knowledge and support for regulatory deficiency responses, regulatory annual reports and the development of other regulatory submission packages.
- Monitor risk management activities.
- Assist in identifying training needs and requirements to meet quality standards.
- Review and approve Quality Event filings (i.e., CAPA, Change Control, Deviations, OOS and Protocol).
- May perform and/or assist in the material release for production.
- May perform and/or assist with quarantine functions and accountability reviews.
- Performs other related tasks as needed.
- Requires a Bachelor’s Degree in Chemistry, Microbiology, Engineering, Regulatory Sciences or other related science discipline. An Advanced Degree is preferred.
- Related Certifications (i.e., Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma…) preferred.
Job Knowledge, Skills & Experience
- Requires a minimum of 5 years of responsible and progressive QA experience in the pharmaceutical industry and radiopharma/radioisotope development in a cGMP environment.
- Prior experience in implementing a Quality Assurance System (QMS) preferred.
- Ability to adapt and grow a Corporate QA strategy to support the goals of the business as it grows and adds products.
- Prior experience supporting aseptic operations or sterile product in a QA role.
- Knowledge of tools, concepts and methodologies of operational and developmental QA.
- Prior auditing experience along with deviation and lot release support.
- Prior experience with implementing Corrective Action Programs.
- Prior experience with QA under, 21CFR PART 212 and 211.
- Excellent communication, organization, analytical, presentation and computer/pc skills to include proficiency with Microsoft Office 365. Able to communicate complex technical issues to all levels of Personnel, Customers and Management.
- Exceptional attention to detail.
- Solid project management experience.
- Prior experience working with a European team, helpful.
- Approximately 30% travel, domestic and potential overseas to support audits and other Quality initiatives when possible and/or permissible.
- Occasional exposure to moderate environmental variations, above – normal noise levels, and/or unpleasant substances.
- Occupational exposure to radiation.
- Occupational exposure to laboratory chemicals and instruments.
- Remote deployment depending on the Public Health Emergency Status.
- Light to moderate physical exertion, including occasional standing, bending, reaching and lifting to include carrying light to moderate loads of up to 55 pounds.
Zionexa offers a comprehensive employee benefits program including a 401(k) with match, Life, STD, LTD, Health, HSA, Dental, Vision, Vacation, Sick Time…
At Zionexa, we embrace diversity in our principles, culture and our values. Zionexa is proud to be an Equal Opportunity employer. As such, we do not discriminate based on race, religion, coloraturas, national origin, gender, gender identity, gender expression, sexual orientation, age, disabilities, protected veteran or other protected characteristics.
To ensure equal employment opportunities to qualified individuals with a disability, Zionexa, U.S. will make reasonable accommodations for the known disability of an otherwise qualified individual, unless undue hardship on the operation of the business would result.
Recognizing that it will not be possible to respond to every applicant expressing interest, and we will reach out only to those meeting the qualifications, we thank you in advance for your interest in Zionexa.
Keep watching our website as we continue to grow!
Please no phone calls or emails to any employee of Zionexa regarding any position opening. To all Agencies, resumes submitted by search firms/employment agencies to any employee at Zionexa by email, internet or in any form and/or method will be deemed the sole property of Zionexa, unless a search firm/employment agency was engaged by Zionexa for a particular position and a valid agreement with Zionexa was in place. Should a candidate who was submitted outside of the Zionexa agency process be hired, no fee or payment of any kind will be paid.