Senior Director, R&D Quality Assurance (GCP/GLP/GVP)

Acceleron Pharma

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 01/07/2021
  • Website: acceleronpharma.com
  • Company Address: 128 Sidney Street, Cambridge, MA, 02139

About Acceleron Pharma

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Job Description

What’s in it for you?

The Senior Director of R&D Quality Assurance (QA) will be responsible for the development and maintenance of the R&D Quality Systems ensuring global regulatory compliance across Acceleron’s portfolio.  This leader will be skilled at managing multiple GxP disciplines, specifically: Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP).  As a thought-leader, the incumbent will provide strategic direction and build a right-sized R&D quality organization.  This leader fosters strong collaboration with senior business partners, offers balanced & objective quality counsel, and has a proven track record of building R&D Quality organizations. 

What will you be doing?

  • Ensure a complete portfolio of GCP/GLP/GVP policies, procedures, and work practices are established and consistently performed across R&D.
  • Provide strategic direction to the R&D Quality organization through goal alignment, proposing continuous improvement initiatives, and educating the organization on best-in-class practices.
  • Provide oversight of quality related processes, systems, and deliverables such as strategic audit plans, quality agreements, issue management, and CAPA.
  • Monitor the health of Acceleron’s R&D Quality System and quality related KPI’s by establishing metrics.
  • Drive achievement of Corporate and Strategic Quality objectives through leadership & coaching of direct reports and cross-functional influence at the senior level.
  • Accountable for successful inspection readiness, leading inspections, and observation management, including third party vendors.
  • Adopting a partnership model for strategic vendors across GCP/GLP/GVP; influence and improve quality in an outsourcing model.
  • Serve as a strong collaborator across R&D as Acceleron expands our clinical portfolio into new therapeutic areas, territories, and advance our Pharmacovigilance practices.
  • Communicate critical risks to senior leadership, requiring diplomatic and objective representation of the issue(s); ensure proper root cause analysis and strong CAPAs are implemented for non-compliance(s).
  • Support investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities.
  • Advance the Quality Culture and promote inspection readiness mindset through proactive issue management and challenging the norm.
  • Invest deeply in team development plans; serve as a coach and mentor to others.

What are we looking for?

  • R&D QA professional with broad drug/device experience which spans all clinical phases (Phase I to Phase IV).
  • Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations.
  • Direct experience building a QA Pharmacovigilance team, with an emphasis on GVP EMA Modules (i.e. strategic auditing, PSMF, QPPV)
  • Exceptional interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues.
  • Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups where there is no precedent.   
  • Ability to remain objective/autonomous in implementing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
  • Broad experience in IND and CTA filings; NDA/BLA/MAA experience strongly preferred
  • Proven experience building high performing GCP/GLP/GVP Quality teams. The ability to attract and recruit top talent, motivate and empower the team, delegate effectively, celebrate diversity within the team, and manage performance; viewed as an influential leader.
  • A leader who is self-reflective and leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement
  • A sought-after mentor, trusted advisor, and advocate for Quality with the ability to influence change and invest deeply in Acceleron’s mission.
  • Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred
  • 15+ years of relevant experience in a biotech/pharmaceutical setting including a GCP & GVP leadership role

How will you grow with us?

This candidate will advance Acceleron’s innovative pipeline through proactively developing and influencing quality specific standards. As the pipeline progresses, this candidate will increase their strategic planning skills to align pipeline progression to the regulatory climate and global footprint.

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) next year. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.