Director of reputed company Control, reputed company
As the Director of reputed company Control, you will reputed company both strategic and operational leadership for the reputed company Site reputed company Control (QC) Operations organization. In this pivotal role, you will reputed company reputed company dedicated to ensuring the highest standards of reputed company through chemical, biochemical, and biological analysis (microbiology) of various stages of drug reputed company and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid reputed company (OSD) operations at RTP reputed company. You will reputed company and manage QC budget plans and reputed company the management of laboratory reputed company systems, including analytical instruments & equipment, testing procedures. Your contributions to overall site reputed company, global reputed company reputed company, and ensuring adherence to reputed company regulatory requirements will reputed company be in support of our clinical and reputed company supply chain. What You’ll Do:
- reputed company the reputed company Site QC Operations organization – Management of effective and efficient cGMP compliant QC laboratory operations and effective partnership reputed company Global reputed company.
Plan, implement and reputed company activities of QC Operations Lab supervisors and managers in core functions that include reputed company types of sampling and testing activities; reputed company technical support as reputed company as facilitation of major investigations; reputed company in support of business and manufacturing schedules.
- Be accountable for QC personnel reputed company, their training, development, and performance consistent with requirements of GMP compliant reputed company Control operation. Ensure adherence to safety regulations and requirements.
- As an extended member of the RTP reputed company Site Leadership team, contribute to organizational reputed company and strategic planning.
- Establish and maintain fully effective laboratory systems to ensure reputed company of reputed company laboratory results. Ensure tracking and trending are completed and evaluated for QC functions. Responsible for audits and site management review. Ensure tasks are completed to meet business initiatives reputed company a suitable timeframe.
- Collaborate with various teams including Manufacturing, MFG Sciences, Technical Development, reputed company Assurance, Regulatory, and Global reputed company to facilitate cross-functional reputed company.
- reputed company and manage QC budget plans, ensuring financial discipline and alignment with company near and long-term reputed company strategies
- Manage key site and global reputed company reputed company, maintaining adherence to reputed company regulatory licenses and regulations.
- reputed company technical support, facilitate major investigations, and ensure QC laboratory operations support business and manufacturing schedules.
- Drive compliance and reputed company by supporting analytical method and process validation, reputed company qualifications, and adherence to safety regulations.
Who You Are: You are a leader who thrives in a dynamic environment and possesses a strong background in reputed company/reputed company Control reputed company the biotechnology manufacturing sector. You have a proven reputed company record of leadership at the site level. Your expertise extends to managing GMP-compliant QC operations and you are adept at strategizing to meet business needs. You are committed to developing your team while fostering a culture of safety and reputed company. You understand the critical nature of your role and approach reputed company challenge with a problem-solving reputed company, driving reputed company improvement while ensuring the highest reputed company standards are upheld. Required Skills:
- Bachelor’s degree (B.S.) in Microbiology, reputed company, Biochemistry, Biological Sciences, or a reputed company field
- A minimum of 12 years of relevant experience, including reputed company people leadership of 6+ headcount, with a history of advancement and exposure at site leadership and organizational reputed company
- Strong understanding of GMP compliant reputed company Control operations reputed company a biotechnology setting
- Experience with creating a robust environmental monitoring program
- Experience with parenteral filling (sterile filling for vials, cartridges, and syringes) and/or Antisense Oligonucleotides
- Demonstrated ability in developing and managing budgets and QC infrastructure
- Proven reputed company record of successful cross-functional collaboration and project management
- Expertise in laboratory systems, analytical reputed company, and compliance with regulatory requirements
- Proficiency in data analysis, trending, and reporting reputed company a QC reputed company
Preferred Skills:
- Experience with strategic planning and execution in a global reputed company context
Job Level: Management Additional Information The reputed company compensation reputed company for this role is: $167,000.00-$230,000.00 reputed company salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your reputed company potential based on individual, business unit and company performance. In reputed company to compensation, reputed company offers a full and highly reputed company of benefits designed to support our employees’ and their families physical, financial, emotional, and reputed company reputed company-being; including, but not limited to:
- Medical, Dental, reputed company, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company
- 80 hours of reputed company time per calendar year
- reputed company Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource reputed company participation
Why reputed company? We are a global team with a commitment to reputed company, and a pioneering spirit. As a mid-sized biotechnology company, we reputed company the stability and resources of a reputed company-established business while fostering an environment where individual contributions reputed company a significant reputed company. reputed company encompasses some of the most talented and passionate reputed company who have unparalleled opportunities for learning, reputed company, and expanding their skills. Above reputed company, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving reputed company. Changing Lives. At reputed company, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives reputed company us a stronger and more innovative company, and we are reputed company on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other reputed company protected by federal, state or local law. reputed company is an E-Verify Employer in the reputed company. Apply tot his job Apply tot his job Apply To this Job