Director GCP Quality Assurance

Position Summary

• Responsible for working on our Phase III Myelofibrosis program, pelabresib
• Manage inspection preparation readiness and host inspections.
• Conduct and report audits (either directly or using consultants/CROs)
• Further development of the QMS (Quality Management System)
• Perform GCP quality advising, and risk identification and CAPA management.   
• Provide support and guidance during and following internal and external audits, and for regulatory inspections.
• Lead and plan/strategize inspection readiness activities for a program and project, supporting inspection preparation on site at sponsor/vendor/site level.
• Perform/coordinate mock inspection activities.
• Provide leadership and direction for ongoing projects, cross-functional teams, and at management review meetings on GCP related activities/issues and act as GCP expert for Constellation/MorphoSys
• Contribute and implement GCP/GVP/GLP compliance risk-based audit strategy and master audit plan.
• Will be a part of management, planning, conduct, approval, and close-out of audits (e.g., for a specific clinical development drug program(s) or subtype of audit).
• Provide subject matter expertise and participate in the development and review of governing documents (policies, SOPs, etc.)
• Liaise with respective internal functions to assess job role training requirements and participate in the development and execution of GCP/GVP governing documents and related training.
• Maintain an in-depth understanding of business principles, industry trends, and the regulatory environment related to GXP activities.
• Drive process improvement, provide expertise and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
• Represent QA function as assigned in the CTT:
  • Participate in the Protocol Deviations (PD) review meetings to identify the trend analysis and recommendations.

Minimum Education/Skills/Experience

• Bachelor’s degree required or Masters/Ph.D. (optional), in a scientific, health sciences, or quality-related field.
• 10+ years within a pharmaceutical drug development GCP/GVP-related discipline (clinical site and CRO auditing, inspection hosting and management, CAPA and quality management, training, and records management, Governing Document development and implementation). 
• Knowledge of ICH GCP/GVP/GLP, FDA, EMA, other related ICH, FDA and general compliance and audit concepts
• Excellent communication skills, both verbal and written
• Good project management and leadership skills
• Able to work independently as well as in a cross-functional, multi-cultural team.

Preferred (But Not Required)

• Experience at CRO and Sponsor environments
• Experience with Good Pharmacovigilance Practice (GVP)

Culture & Benefits

As a full time, employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more.  We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program.  Our culture is a collaborative work environment, and we believe the unique contributions each of us brings drives our success.

Health and Safety

Full vaccination against COVID 19 is a requirement for this position.

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices.  We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.

Reasonable Accommodations

MorphoSys is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at hr-us@morphosys.com

Pay Transparency Policy Statement

MorphoSys US Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.  However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with MorphoSys US Inc.’s legal duty to furnish information. 41 CFR 60-1.35(c).

Sunshine Act

MorphoSys reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. MorphoSys and potential applicants acknowledge that reimbursement of recruiting expenses for certain licensed healthcare professionals may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a healthcare professional who incurs recruiting expenses as a result of interviewing with MorphoSys that we pay or reimburse, such information may be made publicly available by such government authorities.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Morphosys, US Inc. conducts background screening, reference checks and confirmation of vaccination for COVID-19 as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned.