Summary of Position
“Quality and safety above everything”. That is the unassailable theme that guides everything that we do, every day. We have an unwavering commitment to quality and the production of safe and effective products. Our science and risk-based compliant quality culture is flexible, innovative, and healthcare oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact our success.
Your Diligence Means Our Success
You will be a member of Pherros’ dedicated and highly effective quality assurance operations team. You will evaluate and review manufacturing activities (technical transfers, complex investigations, change controls, and other activities as needed). You may also be involved in Quality Agreements as needed. Your expertise will help in identifying deviations from established standards in the manufacture of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with policies/GMPs. You will engage in batch review/disposition/release activities as required. It is your problem-solving skills that will make us ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
As a Quality Assurance Manager, your team will execute batch release processes and provide oversight of product manufactured internally and externally. You will manage the department’s workload, conduct performance planning, and coach employees. You will also ensure drug product manufacturing is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs). Additional specific responsibilities include:
· Manager quality assurance personnel and ensure appropriate quality systems are in place and that the roles and responsibilities of the quality unit are carried for drug product manufacturing.
· Provide direction for day-to-day activities and decisions associated with the manufacturing of drug product, escalating when appropriate.
· Review and approve GMP documentation including complaints, deviations, investigations, changes, procedures and training.
· Ensure a self-inspection program is in place and participate in internal and external audits.
· Influence cross-functional manufacturing groups to maintain and improve the quality system.
· Foster an inclusive environment where continuous improvement and innovative ideas are implemented.
· Provide guidance, participate in projects, manage own time to meet objectives, plan resource requirements for projects throughout the organization.
· Drive continuous improvement activities.
· Engage in continuous inspection readiness for Quality Assurance.
· Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.
· Ensure appropriate networking and sharing of best practices with corporate compliance colleagues and with other compliance functions.
Qualifications
Must-Have
· Applicant must have a Bachelor’s degree in a science-related field and at least 10 years of relevant experience, including supporting cGMP manufacturing.
· cGMP manufacturing/quality experience, including experience in the resolution of deviations or product defects, application of regulations as related to vendor management programs and other industry quality systems and processes.
· Proactive approach and strong critical thinking skills.
· Strong collaboration, relationship management, and interpersonal skills.
· Excellent written and verbal communication.
· Advanced computer skills in MS Office applications and experience operating within quality enterprise systems.
Nice-to-Have
· Familiarity with a Quality Management System, such as Master Control.
· Experience participating in internal Good Manufacturing Practices (cGMP) audits and support regulatory inspections or corporate audit activities.
· Experience communicating with and influencing internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.
· Experience ensuring appropriate internal networking to develop and maintain close and effective business partner relationships with internal colleagues.
Other Job Details
· Work Location: On Premises, Full Time, Infrequent Travel
Sunshine Act
Pherros Biosciences reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pherros Biosciences to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pherros Biosciences intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pherros Biosciences that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pherros is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pherros also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Quality Assurance and Control
About Us
Careers at Pherros Biosciences are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community in order to unearth new innovative therapies that make the world a healthier place.
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