Maintain and improve the global Quality Management System (QMS) from operational standpoint including but not limited to SOP management, training management, deviation management, change management, etc., and lead the QMS Operations team to ensure GxP inspection readiness.
- Responsible for QMS Operations Team in US & Germany
- Responsible for execution of QM activities by ensuring all systems and processes comply with regulatory requirements.
- Oversee all QMS operations not limited to DMS (Document Management System), Training, Change Control, CAPA and Risk management along with issuance and archival of all GxP documentation through management of document lifecycle and review and approval workflows.
- Facilitate the ongoing implementation and long-term maintenance of the new e-QMS.
- Work with cross functional teams in the GMP & GCP area regarding various compliance initiatives to harmonize QMS processes globally.
- Support the development of quality metrics and KPIs to monitor the performance of the quality systems.
- Maintain advance level of knowledge relative to technical expertise and GxP requirements and industry trends as described in applicable worldwide regulations and provides guidance and interpretation of GxP, regulatory, and compliance standards.
- Backup the Head of CQA/QMS in strategic decisions.
- Previous background directly related to quality assurance, quality systems, auditing, quality management systems or other GxP compliance activities.
- Subject matter expert in GMP and/or GCP requirements.
- Experiences in implementing/maintaining an eQMS such as Trackwise, Veeva Vault.
This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.
- Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
- Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
- Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, touch screens and others.
- Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.
- Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
- Pushing - Exerting force upon an object so that the object moves away from the object.
- Pulling - Exerting force upon an object so that the object moves toward the force.
- Sitting – remaining in a sitting position for at least 50% of the time.
- Standing/Walking - remain on one's feet in an upright position at a workstation.
- Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Travel required: Yes (up to 20%). May require travelling domestically or internationally a few times per year.
Required education and experience
- Bachelor’s degree (preferably in Science or Engineering) is required.
- Experience in pharmaceutical/biotechnology industry with minimum seven (7) years in managing quality or compliance teams.
Preferred education and experience
- Master’s degree in the area of expertise is preferred.
- Experiences in hosting FDA or EMA authority inspections is an asset.
- Experiences in leading an international team at various locations is an asset.
What Immatics Offers
We are a committed and inspired company and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills. In addition, we offer:
- Competitive Total Rewards package
- Base Salary
- Annual Bonus
- Stock Options – based on position level
- 401K plan with company match
- Generous Holiday Time
- Generous Paid Time Off (PTO) for ALL EMPLOYEES regardless of position level
- Full Benefits
- Health Insurance
- Dental/Vision insurance
- Short-Term and Long-Term Disability
- Other voluntary insurance (Pet, Legal Shield Identity Theft Protection, Travel Assistant, Accidental Injury and Critical Illness,)
- Family Medical Leave
- Parental Leave
- Employee Assistance Program
- Life Insurance policy
- Additional Voluntary Life Insurance
- Personal time with the CEO in your first 30 days
- Collaborative and family environment
- Monthly Site meetings with fun team building events
- Participation in the annual Houston BioChili Cookoff
- Themed Holiday party
- Social Community Outreach participation
- Development training and planning
- Various committees to foster collaboration and involvement within Immatics
- Hybrid work schedules (based on position need and supervisor’s approval)
Notice to Third-Party Recruiters/Staffing Agencies
Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@immatics.com, and we will contact you if needed.
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.
This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.