Tbwa Chiat/Day Inc
Director, Supplier Quality Management New Stoughton, MA
Tbwa Chiat/Day Inc, Stoughton, Massachusetts, us, 02072
At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including severe and persistent pain and ADHD.
Hybrid:
Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday. POSITION OVERVIEW
The Director, Supplier Quality Management will play a key role in the quality oversight of Contract Manufacturing Organizations and Contract Laboratories across the Collegium Product portfolio. This role is responsible for the GMP supplier management program which oversees contract manufacturing organizations, testing laboratories and material/service providers. This role will act as interdepartmental liaison to various groups including Manufacturing, Supply Chain and Regulatory Affairs. Additionally, this role manages the review, approval and trending of the QC data provided by our contract testing sites. RESPONSIBILITIES
Maintain the approved supplier list and the yearly audit schedule, internal and external. Manage supplier performance scorecards and present supplier quality metrics to cross functional stakeholders. Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues. Lead the development and maintenance activities of Quality Agreements with GMP suppliers. Lead technical assessments for deviations, investigations, OOS, anomalous results and change controls. Ensure QC framework processes and policies/standards are established, implemented, audited, and continuously improved for the enterprise to ensure cGMP compliance with regulations and guidance documents. Lead the QC data analytics, monitoring & trending program. Provide quality support to CMOs & CTLs as needed during product related inspections. Lead Annual Product Review (APR) activities. Interface, as needed with Health Authorities in support of QC testing inquiries and supplier management activities. REQUIRED LEADERSHIP BEHAVIORS
Leadership Behaviors are a core set of behaviors that vary based on Level in the organization. We have categorized these under Head, Heart, and Guts. Head
Know our Business Think Critically Decide Execute
Heart
Collaborate Develop Communicate Embrace Authenticity
Guts
Be Disruptive Evolve
QUALIFICATIONS
Minimum experience required: 10-15 years of pharmaceutical experience with a minimum 5+ years in Quality Control, Supplier Quality Management, or External Manufacturing Minimum education required: Bachelor’s degree in a relevant scientific discipline, Advanced degree preferred Minimum knowledge required: cGMP, USP/EP compendia and ICH testing requirements Demonstrated knowledge of method transfers and qualifications/validations Strong written and oral communication skills as well as organizational skills Demonstrated leadership capability Ability to travel occasionally (up to 25%) to support project activities Proven ability to conduct investigations, audits and develop presentations analyzing complex data Well organized – a natural ability to be organized in how you think, communicate, and conduct your work Ability to navigate through rapid growth and adapt to rapid change Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required Pay Range: $195,320 - $212,180 USD Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. Apply for this job
First Name * Last Name * Email * Phone Resume/CV What is your current address? LinkedIn Profile Are you authorized to work lawfully in the United States for Collegium Pharmaceutical? * Will you now or in the future require Collegium Pharmaceutical to commence (“sponsor”) an immigration case in order to employ you? * Have you ever been told you are excluded from providing products or services for federal healthcare programs? *
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Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday. POSITION OVERVIEW
The Director, Supplier Quality Management will play a key role in the quality oversight of Contract Manufacturing Organizations and Contract Laboratories across the Collegium Product portfolio. This role is responsible for the GMP supplier management program which oversees contract manufacturing organizations, testing laboratories and material/service providers. This role will act as interdepartmental liaison to various groups including Manufacturing, Supply Chain and Regulatory Affairs. Additionally, this role manages the review, approval and trending of the QC data provided by our contract testing sites. RESPONSIBILITIES
Maintain the approved supplier list and the yearly audit schedule, internal and external. Manage supplier performance scorecards and present supplier quality metrics to cross functional stakeholders. Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues. Lead the development and maintenance activities of Quality Agreements with GMP suppliers. Lead technical assessments for deviations, investigations, OOS, anomalous results and change controls. Ensure QC framework processes and policies/standards are established, implemented, audited, and continuously improved for the enterprise to ensure cGMP compliance with regulations and guidance documents. Lead the QC data analytics, monitoring & trending program. Provide quality support to CMOs & CTLs as needed during product related inspections. Lead Annual Product Review (APR) activities. Interface, as needed with Health Authorities in support of QC testing inquiries and supplier management activities. REQUIRED LEADERSHIP BEHAVIORS
Leadership Behaviors are a core set of behaviors that vary based on Level in the organization. We have categorized these under Head, Heart, and Guts. Head
Know our Business Think Critically Decide Execute
Heart
Collaborate Develop Communicate Embrace Authenticity
Guts
Be Disruptive Evolve
QUALIFICATIONS
Minimum experience required: 10-15 years of pharmaceutical experience with a minimum 5+ years in Quality Control, Supplier Quality Management, or External Manufacturing Minimum education required: Bachelor’s degree in a relevant scientific discipline, Advanced degree preferred Minimum knowledge required: cGMP, USP/EP compendia and ICH testing requirements Demonstrated knowledge of method transfers and qualifications/validations Strong written and oral communication skills as well as organizational skills Demonstrated leadership capability Ability to travel occasionally (up to 25%) to support project activities Proven ability to conduct investigations, audits and develop presentations analyzing complex data Well organized – a natural ability to be organized in how you think, communicate, and conduct your work Ability to navigate through rapid growth and adapt to rapid change Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required Pay Range: $195,320 - $212,180 USD Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. Apply for this job
First Name * Last Name * Email * Phone Resume/CV What is your current address? LinkedIn Profile Are you authorized to work lawfully in the United States for Collegium Pharmaceutical? * Will you now or in the future require Collegium Pharmaceutical to commence (“sponsor”) an immigration case in order to employ you? * Have you ever been told you are excluded from providing products or services for federal healthcare programs? *
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