Director, Product Quality
What’s in it for you?
As the leader of this newly created role, the Director, Product Quality (PQ) is responsible for building the PQ capabilities, providing Quality expertise on cross-functional product teams, centralizing critical CMC quality deliverables for Acceleron’s programs, and supporting regulatory submission activities. As the Quality expert on project teams, the incumbent will work cross-functionally enabling CMC milestones, regulatory strategies, and support product life-cycle management. Key stakeholders include Quality, Technical Operations, Regulatory Affairs, Clinical, Commercial and Program Management.
What will you be doing?
- Build the Product Quality organization, vision, goals, and operating model, as the new leader for this function.
- Provide matrix leadership and Product Quality expertise to CMC project teams in areas such as analytical development, specification development, technical transfer, manufacturing, control strategies, and quality.
- Aide in the development of regulatory submissions; provide strategic Product Quality input to CMC related sections and health authority inquiries; serve as the Quality reviewer and approver as required.
- Provide subject matter expertise as the Product Quality reviewer & approver on CMC documents such as Analytical Development Reports, Stability Reports, Specifications, and Specification Justifications.
- Assess and monitor changes with regulatory impact; provide Product Quality review & approval of changes; oversee the implementation strategy to ensure approvals are secured in the appropriate markets.
- Act as Product Quality expert and point of contact for Product Lifecycle Management initiatives, including manufacturing, aseptic filling, final packaging & labeling, while ensuring compliance across multiple territories.
- Active participation at governance meetings including Specification Review Board, Stability Review Board, Material Review Board, and Quality Management Review; as the Product Quality expert, provide strategic counsel & drive cross-functional alignment; prepare technical presentations as required.
- Responsible for organizing and management of Annual Product Reviews, including, aligning a cross functional team on product and/or process CAPA’s, identifying product trends, and drawing product related conclusions.
- Support inspection readiness from an end-to-end product perspective, including external vendors.
- Serve as a point of escalation for critical quality events, including product complaints.
- Promote a culture of regulatory & compliance understanding by having deep knowledge of specific market requirements needed to achieve product approvals.
- Invest deeply in team development plans; serve as a coach and mentor to others.
What are we looking for?
- Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
- 12+ years of relevant experience with a Bachelor’s degree in a biotech/pharmaceutical setting; direct experience with CMC activities & quality deliverables; 8+years of experience with an advanced scientific degree, MS / PhD.
- Ability to build and lead a diverse, high-performing team; skilled at developing staff and advocating/supporting development opportunities for direct reports.
- A proven capacity to operationalize and lead new teams founded on collaboration, transparency, and integrity.
- A proven track record demonstrating good judgement, decision-making experience, and the ability to influence stakeholders at all levels of the organization.
- Organizationally savvy leader capable of affecting positive outcomes in a productive and cooperative manner.
- Possesses a strong understanding of the drug discovery process, GMP manufacturing, CMC and the associated global requirements enabling the advancement of clinical and commercial assets.
- Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations.
- Clear, concise communication appropriately tailored to a broad audience; measured & diplomatic when presenting risks and issues; increasing proficiency of executive presence. Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues.
- Well-prepared, competent, and confident when interacting with senior leadership, regulatory authorities, and internal and external partners.
- Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups.
- Strong experience authoring & reviewing regulatory submissions, including substantial CMC sections, as well as responding to regulatory inquiries.
- Experience interacting with regulators, including inspection experience is preferred.
- A mentor, trusted advisor, and advocate for Quality with the ability to influence change and invest deeply in Acceleron’s mission.
How will you grow with us?
This candidate will advance Acceleron’s innovative pipeline through proactively developing and influencing CMC outcomes, regulatory submissions, and quality systems. 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.
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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 commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States for the treatment of anemia in certain blood disorders. The Companies are also developing luspatercept for the treatment of chronic anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit https://acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.