Manager Quality Assurance - Translational Production & Quality - cGMP Core

Overview
JOB SUMMARY
At Houston Methodist, the Manager Quality Assurance position is responsible for developing, implementing, and managing strategic Quality Assurance systems and activities aligned with FDA's Pharmaceutical Quality for the 21st Century initiative (Risk-based approach and Quality by Design) for the quality oversight of two Academic GMP facilities involved in product development programs, as well as internal and industry-sponsored clinical trials of finished drug products and cellular therapies.
The manager position responsibilities include managing the daily work activities of the work unit/department staff, ensuring quality, productivity, functional excellence, and efficiency while assisting management in accomplishing strategic and operational objectives. In addition, this position provides guidance to staff and is responsible for staffing, budget compliance, contributing to staffing decisions such as hiring and terminating employment, coaching, and counseling employees on work related performance, and assisting in the development and implementation of policies and procedures to ensure a safe and effective work environment. This position also implements training, monitoring and operations initiatives that assure compliance with ethical and legal business practices and relevant accreditation/regulatory/government regulations.
Houston Methodist Standard
PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
• INTEGRITY: We are honest and ethical in all we say and do.
• COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
• ACCOUNTABILITY: We hold ourselves accountable for all our actions.
• RESPECT: We treat every individual as a person of worth, dignity, and value.
• EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
• Focuses on patient/customer safety
• Delivers personalized service using HM Service Standards
• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
• Intentionally rounds with patients/customers to ensure their needs are being met
• Involves patients (customers) in shift/handoff reports byenabling their participation in their plan of care as applicable to the given job

Responsibilities
PRIMARY JOB RESPONSIBILITIES
Job responsibilities labeled EF capture those duties that are essential functions of the job.
PEOPLE - 30)%

1. Performs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in Translational Production & Quality department. Provides development and mentoring of staff. Meets or exceeds threshold goal for department turnover. Develops direct reports to perform these same functions. (EF)
2. Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. (EF)
3. Facilitates the promotion of teamwork within and between departments; participates and/or leads and facilitates department process improvements as needed. (EF)
4. Meets or exceeds threshold goal for department and/or system metrics on employee engagement indicators: action readiness score, tier level. (EF)
5. Provides management oversight of personnel and regulatory guidance to advance projects from basic research laboratories to regulated environments for pre-clinical, GLP, cGMP, early phase clinical projects.

SERVICE - 20)%

1. Plans and organizes day-to-day Translational Production & Quality department operations, schedule and activities. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction. (EF)
2. Drives department service standards and activities to impact department and/or system score for patient/customer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the Translational Production & Quality department. (EF)
3. Provides strategic GMP quality/compliance guidance to internal investigators and external
4. Serves as GMP QA subject matter expert in the review and approval of stability protocols/reports, test method validations and specifications as well as resolution of investigations, deviations and out of specification investigations. (EF)

QUALITY/SAFETY - 30%

1. Ensures a safe and effective working environment; monitors and/or revises the Translational Production & Quality department safety plan and/or any specific accreditation/regulatory required safety guidelines. (EF)
2. Uses and optimizes information systems to enhance operations; supports entity-specific performance improvement and data management/analysis functions. (EF)
3. Employs a proactive approach in the optimization of safe outcomes by monitoring and improving the department workflow, using peer-to-peer accountability, and identifying solutions via collaboration. Adopts lean principles in driving process improvements. Role models situational awareness, using teachable moments to improve safety. (EF)
4. Monitors self and employee compliance with policies, procedures, and System HR Standards of Practice and performs associated actions upon non-compliance (i.e., focal point review requirements, disaster plan, inservices, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.). (EF)
5. Maintains and implements a robust Quality Management System supporting the development and manufacture of drug substances and drug products. (EF)
6. Employs cGMP QA expertise and principles during the development, manufacturing, testing, packaging and release of materials for pre-clinical and clinical studies to ensure product quality. Develops project solutions and provide oversight of compliance for projects/programs in order to achieve strategic goals. (EF)
7. Oversees and conducts final release and disposition of clinical trials material. (EF)

FINANCE - 10%

1. Assists in the development of department budget and ensures that the department operates in a cost effective manner. Manages/audits department expenses within approved budget parameters, ensuring that the Translational Production & Quality Assurance department meets the budgeted/flex revenue and/or expense targets on a monthly and annual basis. Develops staffing plans and schedules to meet department needs that reflect understanding of the importance of cost-effectiveness. (EF)
2. Implements department strategies to achieve financial target and staffing needs, developing others to do the same, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications. (EF)

GROWTH/INNOVATION - 10%

1. Identifies and implements innovative solutions for practice or workflow changes to improve department operations or other department-specific measures by leading unit projects and/or other department/system directed activities. Supports change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures. (EF)
2. Proactively evaluates processes; recommends and implements action plan(s) for change. Participates in the development and implementation of new procedures and the review and revision of existing procedures. (EF)
3. Identifies opportunities and takes action to build strategic relationships between one's area and other areas, teams, departments, and units to achieve business goals. (EF)
4. Seeks opportunities to identify developmental needs of self and staff and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the individual development plan (IDP) on an on-going basis. Conducts conversations with staff on their development and IDP. (EF)

This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Qualifications
EDUCATION REQUIREMENTS

• Bachelor's degree in life sciences or related field from an accredited college or university required. Master's degree preferred.

EXPERIENCE REQUIREMENTS

• Minimum of 5 years of pharmaceutical manufacturing, packaging or laboratory experience including at least 3 years in GMP QA/QC/Compliance.

License/Certification
CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

• Quality Auditor certification (CQA) preferred.

KSA/ Supplemental Data
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
• Ability to effectively communicate through a variety of channels with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles; engages the recipient(s) and helps them understand and retain the message
• Demonstrates the ability to interact with others in a way that gives them confidence in one's intentions and those of the organization
• Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations and individuals involved
• Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills
• Ability to identify and understand issues, problems and opportunities, comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints and probable consequences
• Ability to work effectively in a fast paced environment
• Demonstrates flexibility and adaptability in the workplace
• Demonstrates knowledge of US and International GMP regulations and subsequent applications to pre-clinical and clinical drug development.
• Demonstrates thorough understanding of creation/review/approval of GMP documents including: specifications, test methods, stability protocols, batch records and investigations.

SUPPLEMENTAL REQUIREMENTS
Work AttireYes/NoUniformNoScrubsNoBusiness professionalYesOther (dept approved)No
On-Call* Yes, on a limited basis (for Exempt jobs only)
*Note that employees may be required to be on-call during emergencies (i.e. Disaster, Severe Weather Event, etc.) regardless of selection above.
Travel**
May require travel withinYesHouston Metropolitan area
May require travel outsideYesof Houston Metropolitan area
**Travel specifications may vary by department.
Please note any other special considerations to this job:
Company Profile
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.