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Senior Principal Combination Product Quality Engineer (Associate Director)

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Biogen

Aug 3

Applications are closed

  • Job
    Full-time
    Expert / Leadership (9+ years)
  • Cambridge

Requirements

  • **Required Skills:**
  • Bachelor's Degree in Engineering
  • Minimum 10 years' experience in Combination Product R&D or Device Quality Engineering within the Pharmaceutical/Biotech industries.
  • Proficient understanding of Design Controls, cGMP, ISO 13485, QSR (21 CFR Part 820), and ISO 14971.
  • Proven track record in verification & validation plans and user needs translation.
  • Strong grasp of Risk Management for combination products and medical devices.
  • Familiar with statistical tools and validation/verification techniques.
  • Demonstrated ability in regulatory filings and inspection facilitation.
  • Experience in matrix organization and exceptional communication skills.
  • Strong project management, negotiation, and interpersonal skills.
  • **Preferred Skills:**
  • Master’s degree with 8+ years or a PhD with 4+ years of experience in Combination Product R&D or Device Quality Engineering within the Pharmaceutical/Biotech industries
  • Experience with Class III medical devices.
  • Quality certifications (e.g., CQE, Six Sigma).
  • 1+ years of people management experience.

Responsibilities

  • Provide Subject Matter Expertise in combination products, guiding quality engineering function on related issues.
  • Lead the execution of Design Control processes across all stages of product development.
  • Ensure compliance with global quality standards by reviewing and approving technical documentation.
  • Guide R&D and manufacturing design processes to implement effective Design Control principles.
  • Manage external relationships with device suppliers and testing partners, ensuring adherence to quality standards.
  • Spearhead continuous improvement initiatives within the device and combination product Quality Management System (QMS).
  • Support regulatory filings and audits, acting as the final Quality approval authority for device sections.
  • Participate in internal and external audits and facilitate regulatory inspections.

FAQs

What is the primary focus of the Senior Principal Combination Product Quality Engineer role?

The primary focus is to provide comprehensive quality oversight for the lifecycle management of combination products, ensuring compliance with local and global regulations while driving continuous improvement efforts.

What qualifications are required for this position?

A Bachelor's Degree in Engineering and a minimum of 10 years of experience in Combination Product R&D or Device Quality Engineering within the Pharmaceutical/Biotech industries are required.

Is there a preferred educational background for candidates?

Yes, candidates with a Master’s degree and 8+ years or a PhD with 4+ years of experience in Combination Product R&D or Device Quality Engineering are preferred.

What experience is necessary with regulatory filings?

Candidates must have demonstrated ability in regulatory filings and inspection facilitation.

What kind of products will the Senior Principal Combination Product Quality Engineer oversee?

This role will oversee combination products, specifically in the context of medical devices and biopharmaceuticals.

Are there any specific quality standards that candidates should be familiar with?

Yes, proficiency in understanding Design Controls, cGMP, ISO 13485, QSR (21 CFR Part 820), and ISO 14971 is required.

What skills are necessary related to risk management?

A strong grasp of Risk Management for combination products and medical devices is essential for this role.

Will the role involve managing external partnerships?

Yes, the role includes managing external relationships with device suppliers and testing partners to ensure adherence to quality standards.

Are there any management responsibilities in this position?

Yes, there is a preference for candidates with at least 1 year of people management experience.

Does the company emphasize diversity and inclusion in its workforce?

Yes, Biogen is committed to building a culture of inclusion and belonging that reflects the diverse communities where it operates and the patients it serves.

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Biogen

Science & Healthcare
Industry
5001-10,000
Employees
1976
Founded Year

Mission & Purpose

Biogen is a global biotechnology company that specialises in the discovery, development, and delivery of innovative therapies for neurological and neurodegenerative diseases. They focus on researching and creating treatments for conditions such as multiple sclerosis (MS), spinal muscular atrophy (SMA), and Alzheimer's disease. Biogen's ultimate mission is to pioneer new approaches in biotechnology to address unmet medical needs and improve the lives of patients worldwide. Their purpose is to transform scientific discoveries into therapies that have a significant impact on patients' lives, aiming to provide hope, relief, and improved outcomes for individuals suffering from debilitating neurological disorders. Biogen's commitment lies in advancing the understanding and treatment of neurological conditions through cutting-edge research, development of innovative therapies, and collaboration with healthcare professionals and patient communities.

Culture & Values

  • Customer Focused

    We keep patients, payers and physicians front and center in our daily work and collaborate to solve critical scientific and business challenges. We listen with empathy to respond to current needs and to develop the foresight to anticipate future needs. We drive success through win-win outcomes.

  • Inclusive

    We embrace and leverage differences to foster an inclusive community, both internally and externally. We collaborate across teams, break down siloes and encourage diverse perspectives and backgrounds at all levels to optimize performance. We exhibit mutual respect in all our interactions and assume best intent. We treat everyone with care and dignity.

  • Pioneering

    We challenge the status quo and experiment to create new possibilities. We take calculated risks and learn from failure. We are resilient and navigate through ambiguity with determination to innovate. We encourage candor to test assumptions and uncover the best ideas. We are open about what we do not know and ask questions to understand.

  • Agile

    We are decisive and execute with efficiency and discipline. We adapt in response to internal changes and external disruptors. We develop solutions quickly to take advantage of emerging opportunities. We design and implement processes that enable us to operate nimbly and effectively.

  • Accountable

    We set clear, aligned and measurable objectives to drive results. We directly communicate our expectations and define clear roles and responsibilities. We honor our commitments and deliver on our goals. We assume responsibility for both the positive and negative impacts of our actions and decisions.

  • Ethical

    We never compromise our integrity. We are committed to sustaining an environment of trust, honesty and transparency while ensuring appropriate confidentiality. We do what we say and say what we mean. We take responsibility for upholding our reputation.

Benefits

  • Medical, vision and dental plans

  • On-site fitness centers, with allowances or reimbursement options

  • Competitive compensation

  • Retirement or savings plans

  • Generous paid time off

  • Flexible work arrangements and summer hours