Selkirk Pharma, Inc.
Sr. Director of Quality Assurance/Site Head of Quality
Selkirk Pharma, Inc., Washington, District of Columbia, us, 20022
DescriptionThis leadership position is responsible for the design, development and maintenance of a phase-appropriate, risk-based Quality Management Program ensuring high quality products are manufactured at Selkirk. This role plays a crucial role in overseeing the quality management systems to meet regulatory and industry standards for US and European markets while improving business performance and efficiency.This position delivers quality leadership to the site by providing guidance and interpretation of regulatory requirements and leads the Quality Assurance organization to generate a strong quality culture. Responsible for measuring the effectiveness of the QMS highlighting areas of risk/improvement to site.About UsAt Selkirk, our mission is simple: we want to be the world’s most reliable manufacturer of injectable drug products. As a new aseptic fill/finish contract manufacturer in Spokane, WA, every team member plays a critical role in helping us reach our vision of a world where safe and effective medication is accessible for every patient, every time it’s needed.No matter your role at Selkirk Pharma, successful team members champion our values:Sincerity:
We can work through anything if we are totally honest with ourselves and each other.Gratitude:
So many good things come from gratitude: Dedication. Patience. Positivity. Kindness. We try to be actively grateful every day.Humility:
To achieve greatness, we must be humble and self-aware in pursuit of our goals.Enthusiasm:
We intentionally bring an uncommon energy to every aspect of our work.Team:
Our team is the nucleus around which everything else in our company is built.What You’ll DoLeads Selkirk’s Quality Unit and the broader company by example, with a daily commitment to Selkirk values.Collaborates regularly with cross-functional stakeholders to provide Quality Unit input, assessment, and strategies as appropriate.Manages and coordinates communication between cross-functional teams across the organization to drive quality improvements.Provides quality leadership through a cross-functional partnership with key internal and external stakeholders to build a robust quality culture.Leads, develops, implements, and maintains quality strategies, procedures, and systems in alignment with regulatory guidelines and company objectives.Staffs and oversees employees responsible for developing and executing quality systems in a pharmaceutical environment.Manages Quality Department staff including Quality Engineering, Quality Systems, and Quality Operations & Inspection.Establishes and directs the implementation of departmental and staff objectives, goals, policies and budgets. Monitors, reports and reviews performance against these goals, plans and budgets on a routine basis.Conducts regular performance management and development discussions with team members, and tracks and documents performance versus objectives.Oversees the management of systems including deviations, CAPAs, change control, QA On-The-Floor, raw material inspection and release, product inspection, document control, training, and other quality programs supporting the manufacturing of sterile injectables.Serves as a Quality Unit approver on systems requiring Quality Unit oversight and approval.Develops, monitors, reports, and is responsible for the performance of the Quality Systems KPIs.Engages with clients and regulatory authorities to support audits and other technical meetings.Evaluates and implements best practices balancing scientific information, industry best practices, operational constraints and goals, along with regulatory requirements.Maintains and shares knowledge of the most current regulations to ensure quality compliance.Ensures continued compliance with FDA, EMA and other regulatory agencies as necessary to meet client filing and production strategies.Hosts and facilitates regulatory inspections including supporting inspection readiness, developing responses to regulatory findings, and communicating with regulatory bodies as required.We’re Looking for Someone who Has:Bachelor’s degree in chemistry, Biology, Engineering or other similar scientific discipline.Fifteen (15) years of progressive experience in a regulated cGMP pharmaceutical environment.Seven (7) years in a Quality leadership role.Contract Manufacturing (CMO/CDMO) experience highly preferred.Experience working directly with clients and regulatory bodies demonstrating a high level of GMP expertise.Knowledge of FDA cGMP, GAMP 5, 21CFR Part 11, Eudralex Volume 4 Annex 1, ICH, ISPE and other industry related guidance documents.Experience managing regulatory agency audits (FDA, EMA, ANVISA, PMDA, etc).Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.Experience utilizing multiple software programs: Electronic batch records (eBR), electronic Quality Management Systems (QMS), Document Management System (DMS), Laboratory Information Management Systems (LIMS).Experience utilizing multiple software programs: Building Automation System (BAS), Supervisory Control and Data Acquisition (SCADA), Enterprise Resource Planning (ERP) experience preferred.This is an
on-site,
full-time, exempt position, located in Spokane, WA.Compensation:
$165,000 - 209,000 annually. See full list of benefits below for our complete compensation package.What You’ll Love About UsCompany Culture:
Did someone say Taco Bar? As food fanatics, we like to find any reason to enjoy some good food together.Rest and Relaxation:
160 hours of PTO (pro-rated based on hire date), 52 hours of sick time (pro-rated based on hire date), and 10 paid holidays.Bereavement Leave:
5 days per event.Expand your Family:
Paid Maternity/Paternity Leave – 160 hours per occurrence.Health Benefits:
Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&D.Employee Assistance Plan:
Counseling sessions, legal services, financial services, and more.Prepare for the Future:
Stock options and 401(k) with no vesting period (100% match on the first 3% and 50% on the next 2%).When Duty Calls:
Jury Duty that is. We offer up to 10 days per event.Cell Phone Stipend:
$10 per month.
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We can work through anything if we are totally honest with ourselves and each other.Gratitude:
So many good things come from gratitude: Dedication. Patience. Positivity. Kindness. We try to be actively grateful every day.Humility:
To achieve greatness, we must be humble and self-aware in pursuit of our goals.Enthusiasm:
We intentionally bring an uncommon energy to every aspect of our work.Team:
Our team is the nucleus around which everything else in our company is built.What You’ll DoLeads Selkirk’s Quality Unit and the broader company by example, with a daily commitment to Selkirk values.Collaborates regularly with cross-functional stakeholders to provide Quality Unit input, assessment, and strategies as appropriate.Manages and coordinates communication between cross-functional teams across the organization to drive quality improvements.Provides quality leadership through a cross-functional partnership with key internal and external stakeholders to build a robust quality culture.Leads, develops, implements, and maintains quality strategies, procedures, and systems in alignment with regulatory guidelines and company objectives.Staffs and oversees employees responsible for developing and executing quality systems in a pharmaceutical environment.Manages Quality Department staff including Quality Engineering, Quality Systems, and Quality Operations & Inspection.Establishes and directs the implementation of departmental and staff objectives, goals, policies and budgets. Monitors, reports and reviews performance against these goals, plans and budgets on a routine basis.Conducts regular performance management and development discussions with team members, and tracks and documents performance versus objectives.Oversees the management of systems including deviations, CAPAs, change control, QA On-The-Floor, raw material inspection and release, product inspection, document control, training, and other quality programs supporting the manufacturing of sterile injectables.Serves as a Quality Unit approver on systems requiring Quality Unit oversight and approval.Develops, monitors, reports, and is responsible for the performance of the Quality Systems KPIs.Engages with clients and regulatory authorities to support audits and other technical meetings.Evaluates and implements best practices balancing scientific information, industry best practices, operational constraints and goals, along with regulatory requirements.Maintains and shares knowledge of the most current regulations to ensure quality compliance.Ensures continued compliance with FDA, EMA and other regulatory agencies as necessary to meet client filing and production strategies.Hosts and facilitates regulatory inspections including supporting inspection readiness, developing responses to regulatory findings, and communicating with regulatory bodies as required.We’re Looking for Someone who Has:Bachelor’s degree in chemistry, Biology, Engineering or other similar scientific discipline.Fifteen (15) years of progressive experience in a regulated cGMP pharmaceutical environment.Seven (7) years in a Quality leadership role.Contract Manufacturing (CMO/CDMO) experience highly preferred.Experience working directly with clients and regulatory bodies demonstrating a high level of GMP expertise.Knowledge of FDA cGMP, GAMP 5, 21CFR Part 11, Eudralex Volume 4 Annex 1, ICH, ISPE and other industry related guidance documents.Experience managing regulatory agency audits (FDA, EMA, ANVISA, PMDA, etc).Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.Experience utilizing multiple software programs: Electronic batch records (eBR), electronic Quality Management Systems (QMS), Document Management System (DMS), Laboratory Information Management Systems (LIMS).Experience utilizing multiple software programs: Building Automation System (BAS), Supervisory Control and Data Acquisition (SCADA), Enterprise Resource Planning (ERP) experience preferred.This is an
on-site,
full-time, exempt position, located in Spokane, WA.Compensation:
$165,000 - 209,000 annually. See full list of benefits below for our complete compensation package.What You’ll Love About UsCompany Culture:
Did someone say Taco Bar? As food fanatics, we like to find any reason to enjoy some good food together.Rest and Relaxation:
160 hours of PTO (pro-rated based on hire date), 52 hours of sick time (pro-rated based on hire date), and 10 paid holidays.Bereavement Leave:
5 days per event.Expand your Family:
Paid Maternity/Paternity Leave – 160 hours per occurrence.Health Benefits:
Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&D.Employee Assistance Plan:
Counseling sessions, legal services, financial services, and more.Prepare for the Future:
Stock options and 401(k) with no vesting period (100% match on the first 3% and 50% on the next 2%).When Duty Calls:
Jury Duty that is. We offer up to 10 days per event.Cell Phone Stipend:
$10 per month.
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