Director, Quality Systems

2 weeks ago

Boston, United States Ironwood Pharmaceuticals Full time

 

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Position Summary:

Reporting to the Head of Quality, this individual will be tasked with setting-up, maintaining and further developing the internal GxP quality management system (QMS), learning management system (LMS) and associated quality policies, procedures, and standards to fully support Ironwood's drug development and commercialization activities.  In addition, this individual will be responsible for directly supporting the organization, coordination, and management of Regulatory Agency inspections and audits by external parties at Ironwood Pharmaceuticals, Inc. and to present all QMS related topics to inspectors/auditors.

As the Head of the Quality Systems and Compliance group, this individual will provide proactive leadership and direction, enable growth and development of Quality staff, and promote cross-functional collaboration with Quality business partners, both internal and external.

 

Responsibilities:


Promote the Quality culture and philosophy companywide.
Support the Head of Quality in developing and implementing the overall Quality strategy.
Manage one or more full-time staff responsible for maintaining GxP Quality controlled documents and coordinating GxP compliance training.
Maintain and further develop the global Quality Management System (QMS), the GxP Learning Management System (LMS) and other GxP related systems and provide periodic updates to Quality and Executive Management.
Function as the business owner of the Ironwood QMS, LMS and other applicable GxP e-systems in support of the Ironwood GxP computer system validation program (i.e., assessments, validation, and change control, etc.) to ensure compliance with GxP regulations during the e-system lifecycle.
Develops metrics for non-compliance trends and signals.
Supports the preparation and conduct of GxP relevant Governance Meetings.
Ensure Quality Systems and Compliance personnel, along with internal business partners, maintain a state of GxP compliance and inspection readiness.
Generate key Quality metrics and indicators to measure, trend, manage and improve pharmaceutical quality systems and ensure trends are escalated appropriately.
Directly support the organization, coordination, and management of Regulatory Agency inspections and audits by external business partners
Develop, implement, and support continuous process improvements across multiple GxP disciplines.
Support the management of the field alert and recall processes and communications.
Ensure cross functional alignment of goals and objectives from pre-clinical to commercial phase programs and products, ensuring GXP compliance and realization of other value-added guidelines and best practices.
Support internal and external GxP qualification and audit activities.
Foster an environment conducive to innovation, productivity, and efficiency.
Perform other duties as assigned.


 

Requirements:


Bachelor's degree or higher in Life Sciences, Chemistry, or related field.
Minimum 12 years’ experience in the pharmaceutical industry working in a regulated environment.
Minimum 10 years’ experience in a Quality Systems role.
Minimum 5 years’ experience managing personnel.
Working knowledge of regional GxP rules and regulations
Experienced in managing and actively supporting Health Authority inspections.
Strong knowledge of industry (e.g., FDA, EU, GxP, ICH, ISO, WHO, etc.) regulations and best practices
A deep understanding of the pharmaceutical industry with solid, organization, and structure is preferred.
In-depth knowledge of pharmaceutical quality systems, principles, and applications.
Ability to identify and explain complex issues and provide multiple solutions in a constructive, respectful manner.
Sound leadership skills.


 

 

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

 

Ironwood currently anticipates that the initial base salary for this position could range from between $197,000 to $229,320.  The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

 

  • Associate Director/Director, Quality Systems and Documentation

    Found in: beBee jobs US - 2 weeks ago

    Greater Boston Area, United States Scorpion Therapeutics Full time

    Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data...

  • Director, Quality Systems

    5 days ago

    Boston, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...

  • Director, Quality Systems

    1 week ago

    Boston, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...

  • Director of Quality

    1 week ago

    Boston, United States Rbw Consulting Full time

    Director of Quality, Boston, MA RBW Consulting are collaborating with an established CDMO with a complex portfolio of Sterile products. With over 19 years experience in the industry, they are focusing on expanding their departments for 2024. Their state-of-the-art facilities and experienced team enable us to deliver high-quality products to our clients in...

  • Director of Quality

    1 week ago

    Boston, United States RBW Consulting Full time

    Director of Quality, Boston, MARBW Consulting are collaborating with an established CDMO with a complex portfolio of Sterile products. With over 19 years experience in the industry, they are focusing on expanding their departments for 2024. Their state-of-the-art facilities and experienced team enable us to deliver high-quality products to our clients in the...

  • Director of Quality

    Found in: Appcast US C2 - 1 week ago

    Boston, United States RBW Consulting Full time

    Director of Quality, Boston, MARBW Consulting are collaborating with an established CDMO with a complex portfolio of Sterile products. With over 19 years experience in the industry, they are focusing on expanding their departments for 2024. Their state-of-the-art facilities and experienced team enable us to deliver high-quality products to our clients in the...

  • Director of Quality

    6 days ago

    Boston, United States Rbw Consulting Full time

    Director of Quality, Boston, MA Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck. RBW Consulting are collaborating with an established CDMO with a complex portfolio of Sterile products. With over 19 years experience in the industry, they are focusing on expanding their departments...

  • Director of Quality

    Found in: Appcast Linkedin GBL C2 - 1 week ago

    Boston, United States RBW Consulting Full time

    Director of Quality, Boston, MARBW Consulting are collaborating with an established CDMO with a complex portfolio of Sterile products. With over 19 years experience in the industry, they are focusing on expanding their departments for 2024. Their state-of-the-art facilities and experienced team enable us to deliver high-quality products to our clients in the...

  • Director, Quality Systems

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...

  • Senior Director BIS Quality

    1 day ago

    Boston, United States Blackwomenintech Full time

    As argenx continues to grow and evolve, we are looking for a Senior Director BIS Quality. The Senior Director BIS Quality is responsible for both the strategic direction as well as the day-to-day operations and coordination of all activities relating to the argenx Computer Systems Assurance (CSA) Process. This includes GxP systems, Regulated systems and...

  • Associate Director/Director of Quality Systems Management

    1 week ago

    Boston, United States CareerBuilder Full time

    About Us: Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. We have a lead program that we expect...

  • Director of Quality Control

    1 week ago

    Boston, United States CareerBuilder Full time

    Director of Quality Control About the Company Renowned public accounting firm Industry Accounting Type Privately Held About the Role The Director of Quality Control will be responsible for overseeing the organization's audit work papers and reports as well as developing robust audit quality controls. Travel Percent Less than 10% Functions General Management...

  • Director of Quality

    Found in: Jooble US O C2 - 2 days ago

    Boston, MA, United States RBW Consulting Full time

    Director of Quality, Boston, MA RBW Consulting are collaborating with an established CDMO with a complex portfolio of Sterile products. With over 19 years experience in the industry, they are focusing on expanding their departments for 2024. Their state-of-the-art facilities and experienced team enable us to deliver high-quality products to our clients in...

  • Director/Assoc Director Regulatory Affairs

    Found in: Talent US C2 - 2 weeks ago

    Boston, United States Apex Systems Full time

    Job#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location:  Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...

  • Senior Director of Human Resource Systems

    1 week ago

    Boston, United States Tandym group Full time

    A biopharma company in Massachusetts is looking to add a new Senior Director / Head of Human Resource Systems to their team. In this role, the Senior Director / Head of Human Resource Systems will be responsible for acting as a key member of highly collaborative HR and corporate teams with responsibility for Human Resource management systems, data and...

  • Global Quality Director

    Found in: beBee jobs US - 1 week ago

    Boston, Massachusetts, United States PerkinElmer Full time

    The CompanyPerkinElmer is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937, PerkinElmer has served as a trusted partner in laboratory analysis and...

  • Global Quality Director

    Found in: beBee jobs US - 2 weeks ago

    Boston, Massachusetts, United States PerkinElmer Full time

    Responsibilities Location Boston, MassachusettsUS Job ID REQ-052568 The CompanyPerkinElmer is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937,...

  • Director of Quality Assurance and Compliance

    1 week ago

    Boston, United States Stavis Seafoods Full time

    Stavis Seafoods, A Profand Company, an anchor of the New England seafood community since 1929, ships more than 37 million pounds of fresh and frozen seafood annually and imports from more than 50 countries worldwide. Stavis has one of the most diverse inventories of seafood items in the industry and can ship via land, air and sea around the globe. In 2018...

  • Director of Quality Assurance and Compliance

    6 days ago

    Boston, United States Stavis Seafoods Full time

    Stavis Seafoods, A Profand Company, an anchor of the New England seafood community since 1929, ships more than 37 million pounds of fresh and frozen seafood annually and imports from more than 50 countries worldwide. Stavis has one of the most diverse inventories of seafood items in the industry and can ship via land, air and sea around the globe. Are you...

  • Director of Quality Assurance and Compliance

    Found in: Appcast US C2 - 2 weeks ago

    Boston, United States Stavis Seafoods Full time

    Stavis Seafoods, A Profand Company, an anchor of the New England seafood community since 1929, ships more than 37 million pounds of fresh and frozen seafood annually and imports from more than 50 countries worldwide. Stavis has one of the most diverse inventories of seafood items in the industry and can ship via land, air and sea around the globe.In 2018...