- Provide GCP QA and compliance support to Morphic's clinical development programs to ensure overall clinical study and GCP compliance based on risk-based principles.
- Provide interpretation and guidance for internal and external customers on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies.
- Collaborate with internal and external Study Team members and vendors to develop and execute strategic plans to identify, mitigate, monitor, and report site, study and program level compliance risks and mitigation plans.
- Assist in the identification, escalation, and resolution of potential compliance issues within Morphic, as well as at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the
- Maintain and report CQA metrics to senior leadership and functional areas to facilitate process improvements.
- Lead or participate in the conduct and management of GCP audits (Internal, Clinical Sites, Vendors) to ensure compliance with contracted services, GCP guidelines, applicable regulations, company policies and procedures, and SOPs. Assess impact of
- Support inspection readiness and preparation, and lead/ directly support regulatory agency inspections.
- Lead and/or suppo1t coordination of responses to any findings from health authority inspections.
- Coordinate with cross-functional teams (e.g., Program Leads, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance) to develop/implement phase appropriate procedures to ensure consistency and quality with respect to clinical trial support activities at Morphic.
- Conduct a Quality Assurance review of clinical study reports and audit trial master files for applicable regulatory compliance.
- Develop, review, and implement SOPs relating to GCP, as needed; support development and implementation of Morphic's Quality Management System
- Stay abreast of changes in applicable FDA and European regulations, directive and guidelines and determine its impact on clinical studies.
- Identify, develop, and assist in internal and external GCP training, as appropriate.
- Bachelor's degree in the Life Sciences with 7+ years in pharmaceutical or biotech drug development. Advanced degree preferred.
- Minimum 5 years of experience in a GCP compliance/ quality role.
- Demonstrated experience working with clinical trial teams.
- Extensive experience with global clinical trial conduct, knowledge and understanding of ICH GCP Guidelines, FDA Regulations and EU Requirements.
- Previous experience facilitating and/or supporting Regulatory Authority Inspections.
- Direct experience in the use, development, and oversight of Quality Management Systems.
- Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting.
- Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop good working relationships with cross functional personnel at all levels.
- Ability to work collaboratively toward practical solutions to issues.
- Ability to balance multiple priorities in a fast-paced environment in an efficient and effective manner.
- Self-motivated and able to work independently with little to no supervision in a fast-paced small company environment, applying judgment with limited information or guidance, and seeking input as required.
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Sr Manager, GCP Quality Assurance - Waltham, United States - Morphic Holding, Inc.
Description
About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer.
In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology.
For more information, visitMorphic is advancing fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020.
Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept.
Morphic Therapeutic is located in the BioHub in Waltham, MA.We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.
Job Description:
Playing a critical role within Morphic, the Sr.
Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of Morphic' s clinical programs.
The Sr.Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, and Pharmacovigilance as well as external vendors supporting Morphic sponsored clinical studies.
This role will be directly involved in the development and continuous improvement of GCP Quality and overall Quality Management Systems at Morphic as we grow and mature organizationally.
This individual will be responsible for coordinating with key stakeholders to develop, implement, and execute processes and systems governing GCP activities.
The successful candidate will be collaborative and a solution-oriented problem solver.Essential Job Functions:
Position Responsibilities
Qualifications:
Required
Cultural Fit:
Our culture is collaborative, one where people enjoy coming to work.
We are a small, entrepreneurial company where everyone pitches in and works together to do whatever it takes to get things done.
Our team is passionate, enthusiastic, and committed.We have a fast-paced, high accountability environment. We have a flat organization, and our leaders lead through influence and interpersonal skills, not command and control. Everyone on the team, including our CEO, is an individual contributor.
We seek an individual for this position who shares our values and our enthusiasm about bringing new medicines to the patients and families that need them.
We seek someone who will enjoy working in a small company environment and be motivated by theopportunity to directly influence and help shape the future direction and culture of our company.
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees' development and achievement goals.
We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients' lives.
In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.
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