Sarepta Therapeutics
Associate Director, QA Clinical Operations DP
Sarepta Therapeutics, Andover, Minnesota, United States, 55304
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website:
Sarepta Benefits
The Importance of the Role
The Associate Director of QA Clinical Operations DP will manage a team responsible for providing quality oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) and service providers used to manufacture Drug Products (DP) for clinical products. This individual is part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to ensure product quality and compliance. Activities include oversight of process performance qualifications, technology transfers, pre-approval inspection readiness at contract sites, investigations, change controls, and batch disposition. He/she will be responsible for the coordination of the activities of multiple areas in departments with responsibility for results. Objectives with significant impact on the department and organization.
The Opportunity to Make a Difference
Generally provides direction to team members around prioritization of deliverables related to lot release
Responsible for resource allocation and personnel development
Responsible for triage & distribution of internal and external information to team members
Cross-functionally partners with leaders for direction of program
Responsible for analysis and distribution of metrics data
Solution focused; Accountable for problem-solving within team
Monitors metrics of staff and tracking against performance expectations
Supports investigation, deviation activities and CAPAs and provides general quality assurance support for the overall Quality System at Sarepta.
Responsible for multiple direct reports
Typically assists executives and/or senior directors in defining organizational goals and strategic plans
Establishes final decisions on administrative or operational matters and ensures effective achievement of objectives
Manages activities of two or more sections or departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors
Typically works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
Works on objectives that have critical impact on functional area and the organization
Travel to Contract Manufacturing Organizations for periodic meetings is required
More about You
BA/BS degree in a related field, 10+ years related experience
Demonstrated understanding of FDA/ICH GMP/GCP/GLP/GDP requirements and practices, ability to apply and educate team members and cross-functional partners
Electronic Quality Management Systems (eQMS) knowledge
Must have extensive technical knowledge of pharmaceutical manufacturing and laboratory operations
Working knowledge of US & ex-US regulations
Ability to apply phase-appropriate guidance to development
Proficient in Microsoft suite
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid
#LI-ES1
This position is hybrid, you will be expected to work on-site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
#J-18808-Ljbffr
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website:
Sarepta Benefits
The Importance of the Role
The Associate Director of QA Clinical Operations DP will manage a team responsible for providing quality oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) and service providers used to manufacture Drug Products (DP) for clinical products. This individual is part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to ensure product quality and compliance. Activities include oversight of process performance qualifications, technology transfers, pre-approval inspection readiness at contract sites, investigations, change controls, and batch disposition. He/she will be responsible for the coordination of the activities of multiple areas in departments with responsibility for results. Objectives with significant impact on the department and organization.
The Opportunity to Make a Difference
Generally provides direction to team members around prioritization of deliverables related to lot release
Responsible for resource allocation and personnel development
Responsible for triage & distribution of internal and external information to team members
Cross-functionally partners with leaders for direction of program
Responsible for analysis and distribution of metrics data
Solution focused; Accountable for problem-solving within team
Monitors metrics of staff and tracking against performance expectations
Supports investigation, deviation activities and CAPAs and provides general quality assurance support for the overall Quality System at Sarepta.
Responsible for multiple direct reports
Typically assists executives and/or senior directors in defining organizational goals and strategic plans
Establishes final decisions on administrative or operational matters and ensures effective achievement of objectives
Manages activities of two or more sections or departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors
Typically works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
Works on objectives that have critical impact on functional area and the organization
Travel to Contract Manufacturing Organizations for periodic meetings is required
More about You
BA/BS degree in a related field, 10+ years related experience
Demonstrated understanding of FDA/ICH GMP/GCP/GLP/GDP requirements and practices, ability to apply and educate team members and cross-functional partners
Electronic Quality Management Systems (eQMS) knowledge
Must have extensive technical knowledge of pharmaceutical manufacturing and laboratory operations
Working knowledge of US & ex-US regulations
Ability to apply phase-appropriate guidance to development
Proficient in Microsoft suite
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid
#LI-ES1
This position is hybrid, you will be expected to work on-site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
#J-18808-Ljbffr